A Study Of PF-06664178 In Patients With Advanced Solid Tumors
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT02122146
Collaborator
(none)
31
10
1
22
3.1
0.1
Study Details
Study Description
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
31 participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors
Actual Study Start Date
:
Aug 1, 2014
Actual Primary Completion Date
:
Jun 1, 2016
Actual Study Completion Date
:
Jun 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PF-06664178 Experimental |
Drug: PF-06664178
Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.
Drug: PF-06664178
Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.
|
Outcome Measures
Primary Outcome Measures
- First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) [Day 1 up to Day 21]
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
- Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3] [Day 1 up to Day 21]
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
- Number of Participants With Laboratory Abnormalities [Part 2 & 3] [On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)]
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.
Secondary Outcome Measures
- Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1] [From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment)]
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
- Number of Participants With Laboratory Abnormalities[Part 1] [Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)]
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.
- Overall Incidence of Anti-PF-06664178-Antibodies[Part 1] [Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment]
Number of participants with the presence of anti-PF-06664178 antibodies
- Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3] [Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment]
Number of participants with the presence of anti-PF-06664178 antibodies
- Overall Number of Participants With Objective Tumor Response[Part 1] [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months]
Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline.
- Overall Number of Participants With Objective Tumor Response [Part 2 & 3] [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months]
Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In)
- Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Cmax of PF-06664178 was observed directly from data
- Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Cmax of total antibody PF-06479118 was observed directly from data
- Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Cmax of unconjugated payload PF-06380101 was observed directly from data
- Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval
- Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.
- Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.
- Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
- Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
- Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
- Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
- Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
- Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
- Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
- Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
- Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
- Trop-2 Expression Levels on Archived Tissue [Part 2 & 3] [Day 1]
Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression
- Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
- Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
- Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment]
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
-
Performance Status of 0 or 1
-
Adequate bone marrow, kidney and liver function
-
Part 2 includes target expressing NSCLC, ovarian or breast cancer patients
Exclusion Criteria:
-
Brain metastases requiring steroids
-
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
-
Active and clinically significant bacterial, fungal, or viral infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Keck Hospital of USC | Los Angeles | California | United States | 90033 |
| 2 | LAC&USC Medical Center | Los Angeles | California | United States | 90033 |
| 3 | USC/Norris Comprehensive Cancer Center / Investigational Drug Services | Los Angeles | California | United States | 90033 |
| 4 | USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
| 5 | Anschutz Cancer Pavilion | Aurora | Colorado | United States | 80045 |
| 6 | University of Colorado Denver CTO (CTRC) | Aurora | Colorado | United States | 80045 |
| 7 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 8 | Swedish Medical Center | Seattle | Washington | United States | 98104 |
| 9 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
| 10 | University of Washington Medical Center | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02122146
Other Study ID Numbers:
- B7401001
- 2015-002704-84
First Posted:
Apr 24, 2014
Last Update Posted:
Feb 19, 2018
Last Verified:
Aug 1, 2017
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 38 patients were screened, among which 31 were assigned to study treatment. |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Period Title: Part 1: Dose Escalation | ||||||||
| STARTED | 2 | 2 | 4 | 4 | 4 | 6 | 1 | 8 |
| COMPLETED | 1 | 1 | 2 | 3 | 3 | 5 | 0 | 6 |
| NOT COMPLETED | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 2 |
| Period Title: Part 1: Dose Escalation | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Part 1: Dose Escalation | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Total of all reporting groups |
| Overall Participants | 2 | 2 | 4 | 4 | 4 | 6 | 1 | 8 | 31 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
54
(7.1)
|
75
(11.3)
|
61
(17.9)
|
52.8
(20)
|
46
(11)
|
53.7
(11.8)
|
63
(0)
|
61.1
(6.6)
|
57.1
(13.2)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
1
50%
|
0
0%
|
2
50%
|
2
50%
|
1
25%
|
5
83.3%
|
1
100%
|
6
75%
|
18
58.1%
|
| Male |
1
50%
|
2
100%
|
2
50%
|
2
50%
|
3
75%
|
1
16.7%
|
0
0%
|
2
25%
|
13
41.9%
|
Outcome Measures
| Title | First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) |
|---|---|
| Description | Number of participants that experienced dose limiting toxicities(DLTs) at given dose level. |
| Time Frame | Day 1 up to Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who started treatment. One of participants that experienced DLTs in PF-06664178 4.80mg/kg group was a late DLT that occurred at the beginning of Cycle 2 and was classified as a late DLT. |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 2 | 2 | 4 | 4 | 4 | 6 | 1 | 8 |
| Yes |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
33.3%
|
1
100%
|
4
50%
|
| No |
2
100%
|
2
100%
|
4
100%
|
4
100%
|
4
100%
|
4
66.7%
|
0
0%
|
4
50%
|
| Title | Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3] |
|---|---|
| Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. |
| Time Frame | Day 1 up to Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Number of Participants With Laboratory Abnormalities [Part 2 & 3] |
|---|---|
| Description | Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test. |
| Time Frame | On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued) |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1] |
|---|---|
| Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. |
| Time Frame | From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who started treatment |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 2 | 2 | 4 | 4 | 4 | 6 | 1 | 8 |
| Number [participants] |
2
100%
|
2
100%
|
4
100%
|
4
100%
|
4
100%
|
6
100%
|
1
100%
|
8
100%
|
| Title | Number of Participants With Laboratory Abnormalities[Part 1] |
|---|---|
| Description | Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test. |
| Time Frame | Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who started treatment. |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 2 | 2 | 4 | 4 | 4 | 6 | 1 | 8 |
| Number [participants] |
1
50%
|
2
100%
|
4
100%
|
4
100%
|
4
100%
|
6
100%
|
0
0%
|
8
100%
|
| Title | Overall Incidence of Anti-PF-06664178-Antibodies[Part 1] |
|---|---|
| Description | Number of participants with the presence of anti-PF-06664178 antibodies |
| Time Frame | Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who started treatment |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 2 | 2 | 4 | 4 | 4 | 6 | 1 | 8 |
| Number [participants] |
2
100%
|
2
100%
|
4
100%
|
4
100%
|
4
100%
|
6
100%
|
0
0%
|
8
100%
|
| Title | Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3] |
|---|---|
| Description | Number of participants with the presence of anti-PF-06664178 antibodies |
| Time Frame | Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Overall Number of Participants With Objective Tumor Response[Part 1] |
|---|---|
| Description | Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline. |
| Time Frame | Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of all enrolled 31 patients who were treated, 1 participant from the 0.60mg/kg cohort and 1 participant from the 4.20mg/kg cohort did not have post-dose tumor evaluations for they were discontinued form study prior to having disease assessment . |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 2 | 2 | 3 | 4 | 4 | 6 | 0 | 8 |
| SD |
0
0%
|
1
50%
|
1
25%
|
1
25%
|
2
50%
|
4
66.7%
|
2
200%
|
|
| PD |
2
100%
|
1
50%
|
2
50%
|
3
75%
|
2
50%
|
1
16.7%
|
3
300%
|
|
| Sym |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
|
| In |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
300%
|
| Title | Overall Number of Participants With Objective Tumor Response [Part 2 & 3] |
|---|---|
| Description | Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In) |
| Time Frame | Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3] |
|---|---|
| Description | Cmax of PF-06664178 was observed directly from data |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3] |
|---|---|
| Description | Cmax of total antibody PF-06479118 was observed directly from data |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] |
|---|---|
| Description | Cmax of unconjugated payload PF-06380101 was observed directly from data |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3] |
|---|---|
| Description | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3] |
|---|---|
| Description | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3] |
|---|---|
| Description | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3] |
|---|---|
| Description | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] |
|---|---|
| Description | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] |
|---|---|
| Description | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3] |
|---|---|
| Description | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] |
|---|---|
| Description | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] |
|---|---|
| Description | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3] |
|---|---|
| Description | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3] |
|---|---|
| Description | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] |
|---|---|
| Description | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Trop-2 Expression Levels on Archived Tissue [Part 2 & 3] |
|---|---|
| Description | Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| No participant was analyzed due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3] |
|---|---|
| Description | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] |
|---|---|
| Description | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] |
|---|---|
| Description | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. |
| Time Frame | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination |
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse Events
| Time Frame | From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||
| Arm/Group Title | PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg | Total | |||||||||
| Arm/Group Description | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | Treatment Group Description TBD | |||||||||
All Cause Mortality |
||||||||||||||||||
| PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg | Total | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg | Total | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | 1/2 (50%) | 2/4 (50%) | 0/4 (0%) | 1/4 (25%) | 3/6 (50%) | 1/1 (100%) | 5/8 (62.5%) | 13/31 (41.9%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Neutropenia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| General disorders | ||||||||||||||||||
| Disease progression | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Mucosal inflammation | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 2/8 (25%) | 3/31 (9.7%) | |||||||||
| Pain | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Pneumonia | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Urinary tract infection | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| Dehydration | 0/2 (0%) | 1/2 (50%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 2/31 (6.5%) | |||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Pain in extremity | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||
| Malignant pleural effusion | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| Cerebrovascular accident | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Seizure | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Dyspnoea | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/1 (100%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Dermatitis bullous | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Rash | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Toxic epidermal necrolysis | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| PF-06664178 0.15 mg/kg | PF-06664178 0.30 mg/kg | PF-06664178 0.60 mg/kg | PF-06664178 1.20 mg/kg | PF-06664178 2.40 mg/kg | PF-06664178 3.60 mg/kg | PF-06664178 4.20 mg/kg | PF-06664178 4.80 mg/kg | Total | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/2 (100%) | 2/2 (100%) | 4/4 (100%) | 4/4 (100%) | 4/4 (100%) | 6/6 (100%) | 1/1 (100%) | 8/8 (100%) | 31/31 (100%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Anaemia | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 1/4 (25%) | 1/4 (25%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 5/31 (16.1%) | |||||||||
| Febrile neutropenia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Leukocytosis | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Neutropenia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 2/6 (33.3%) | 0/1 (0%) | 5/8 (62.5%) | 8/31 (25.8%) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Sinus tachycardia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 2/31 (6.5%) | |||||||||
| Tachycardia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Ear and labyrinth disorders | ||||||||||||||||||
| Vertigo | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Eye disorders | ||||||||||||||||||
| Conjunctival hyperaemia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Dry eye | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Vision blurred | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 2/31 (6.5%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal distension | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 2/31 (6.5%) | |||||||||
| Abdominal pain | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 1/4 (25%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 3/31 (9.7%) | |||||||||
| Abdominal pain upper | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 3/31 (9.7%) | |||||||||
| Ascites | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 2/31 (6.5%) | |||||||||
| Constipation | 0/2 (0%) | 0/2 (0%) | 2/4 (50%) | 1/4 (25%) | 2/4 (50%) | 1/6 (16.7%) | 0/1 (0%) | 5/8 (62.5%) | 11/31 (35.5%) | |||||||||
| Diarrhoea | 0/2 (0%) | 0/2 (0%) | 2/4 (50%) | 0/4 (0%) | 2/4 (50%) | 2/6 (33.3%) | 0/1 (0%) | 0/8 (0%) | 6/31 (19.4%) | |||||||||
| Dry mouth | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 2/31 (6.5%) | |||||||||
| Dysphagia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Flatulence | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 2/31 (6.5%) | |||||||||
| Gastrooesophageal reflux disease | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Haematemesis | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Lip blister | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Nausea | 0/2 (0%) | 0/2 (0%) | 2/4 (50%) | 0/4 (0%) | 2/4 (50%) | 3/6 (50%) | 0/1 (0%) | 3/8 (37.5%) | 10/31 (32.3%) | |||||||||
| Oral pain | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Palatal disorder | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Stomatitis | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 4/8 (50%) | 5/31 (16.1%) | |||||||||
| Tongue disorder | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Vomiting | 0/2 (0%) | 0/2 (0%) | 2/4 (50%) | 0/4 (0%) | 1/4 (25%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 5/31 (16.1%) | |||||||||
| General disorders | ||||||||||||||||||
| Chills | 0/2 (0%) | 1/2 (50%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 3/6 (50%) | 0/1 (0%) | 4/8 (50%) | 9/31 (29%) | |||||||||
| Early satiety | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 2/31 (6.5%) | |||||||||
| Face oedema | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Fatigue | 0/2 (0%) | 0/2 (0%) | 3/4 (75%) | 1/4 (25%) | 1/4 (25%) | 4/6 (66.7%) | 0/1 (0%) | 4/8 (50%) | 13/31 (41.9%) | |||||||||
| Gait disturbance | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Influenza like illness | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Injection site erythema | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Injection site reaction | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/1 (100%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Local swelling | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Malaise | 0/2 (0%) | 1/2 (50%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Mucosal inflammation | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/1 (100%) | 3/8 (37.5%) | 5/31 (16.1%) | |||||||||
| Oedema peripheral | 0/2 (0%) | 0/2 (0%) | 2/4 (50%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 5/31 (16.1%) | |||||||||
| Pain | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 2/31 (6.5%) | |||||||||
| Pyrexia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 2/6 (33.3%) | 0/1 (0%) | 2/8 (25%) | 5/31 (16.1%) | |||||||||
| Immune system disorders | ||||||||||||||||||
| Hypersensitivity | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Candida infection | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Cellulitis | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 1/6 (16.7%) | 0/1 (0%) | 2/8 (25%) | 4/31 (12.9%) | |||||||||
| Herpes zoster | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Oral candidiasis | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 2/8 (25%) | 3/31 (9.7%) | |||||||||
| Pneumonia | 1/2 (50%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 2/31 (6.5%) | |||||||||
| Pyelonephritis | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Upper respiratory tract infection | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Urinary tract infection | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 3/31 (9.7%) | |||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Excoriation | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Infusion related reaction | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 4/6 (66.7%) | 0/1 (0%) | 2/8 (25%) | 8/31 (25.8%) | |||||||||
| Investigations | ||||||||||||||||||
| Body temperature increased | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Cardiac murmur | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Electrocardiogram QT prolonged | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Eosinophil count increased | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Haematocrit decreased | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Lymphocyte count decreased | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 2/31 (6.5%) | |||||||||
| Neutrophil count decreased | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 2/31 (6.5%) | |||||||||
| Neutrophil count increased | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Platelet count decreased | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Weight decreased | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 2/6 (33.3%) | 0/1 (0%) | 4/8 (50%) | 8/31 (25.8%) | |||||||||
| White blood cell count decreased | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 3/8 (37.5%) | 4/31 (12.9%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| Decreased appetite | 0/2 (0%) | 1/2 (50%) | 3/4 (75%) | 0/4 (0%) | 1/4 (25%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 7/31 (22.6%) | |||||||||
| Dehydration | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 2/31 (6.5%) | |||||||||
| Hypercalcaemia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Hyperkalaemia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Hypokalaemia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Hyponatraemia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 2/8 (25%) | 4/31 (12.9%) | |||||||||
| Hypophagia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Hypophosphataemia | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 2/4 (50%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 4/31 (12.9%) | |||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Arthralgia | 0/2 (0%) | 0/2 (0%) | 2/4 (50%) | 1/4 (25%) | 0/4 (0%) | 2/6 (33.3%) | 0/1 (0%) | 2/8 (25%) | 7/31 (22.6%) | |||||||||
| Back pain | 1/2 (50%) | 0/2 (0%) | 3/4 (75%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 5/31 (16.1%) | |||||||||
| Bone pain | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 1/1 (100%) | 1/8 (12.5%) | 3/31 (9.7%) | |||||||||
| Flank pain | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 2/31 (6.5%) | |||||||||
| Joint stiffness | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Muscle spasms | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Muscular weakness | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Musculoskeletal pain | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 2/4 (50%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 4/31 (12.9%) | |||||||||
| Myalgia | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 3/31 (9.7%) | |||||||||
| Pain in extremity | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| Balance disorder | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Dizziness | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 3/31 (9.7%) | |||||||||
| Dysgeusia | 1/2 (50%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 3/31 (9.7%) | |||||||||
| Encephalopathy | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Headache | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 3/6 (50%) | 0/1 (0%) | 0/8 (0%) | 3/31 (9.7%) | |||||||||
| Hepatic encephalopathy | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Hypoaesthesia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Neuropathy peripheral | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Paraesthesia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Presyncope | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Tension headache | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Tremor | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 2/31 (6.5%) | |||||||||
| Psychiatric disorders | ||||||||||||||||||
| Abnormal dreams | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Confusional state | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 2/31 (6.5%) | |||||||||
| Depressed mood | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Depression | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Hallucination, auditory | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Insomnia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Renal and urinary disorders | ||||||||||||||||||
| Chromaturia | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Dysuria | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 3/31 (9.7%) | |||||||||
| Haematuria | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Pollakiuria | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Proteinuria | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Urinary retention | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Reproductive system and breast disorders | ||||||||||||||||||
| Scrotal erythema | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Cough | 1/2 (50%) | 1/2 (50%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 5/31 (16.1%) | |||||||||
| Dry throat | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Dyspnoea | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 5/31 (16.1%) | |||||||||
| Dyspnoea exertional | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Epistaxis | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Haemoptysis | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Hypoxia | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Nasal congestion | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Oropharyngeal pain | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 3/8 (37.5%) | 5/31 (16.1%) | |||||||||
| Pharyngeal oedema | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Pleural effusion | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Pulmonary embolism | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Wheezing | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 3/31 (9.7%) | |||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Alopecia | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 3/31 (9.7%) | |||||||||
| Blister | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Dry skin | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 2/6 (33.3%) | 1/1 (100%) | 1/8 (12.5%) | 4/31 (12.9%) | |||||||||
| Erythema | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 4/31 (12.9%) | |||||||||
| Facial wasting | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Hyperhidrosis | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 3/31 (9.7%) | |||||||||
| Night sweats | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Palmar erythema | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Palmar-plantar erythrodysaesthesia syndrome | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Pruritus | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) | 2/6 (33.3%) | 0/1 (0%) | 2/8 (25%) | 6/31 (19.4%) | |||||||||
| Pruritus generalised | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 2/31 (6.5%) | |||||||||
| Rash | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) | 2/6 (33.3%) | 0/1 (0%) | 4/8 (50%) | 8/31 (25.8%) | |||||||||
| Rash erythematous | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Rash maculo-papular | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 2/6 (33.3%) | 1/1 (100%) | 1/8 (12.5%) | 5/31 (16.1%) | |||||||||
| Rash pruritic | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 2/8 (25%) | 3/31 (9.7%) | |||||||||
| Red man syndrome | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Skin discolouration | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | |||||||||
| Skin exfoliation | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 1/8 (12.5%) | 2/31 (6.5%) | |||||||||
| Skin lesion | 1/2 (50%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Skin striae | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 1/4 (25%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Skin ulcer | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Vascular disorders | ||||||||||||||||||
| Flushing | 0/2 (0%) | 0/2 (0%) | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Hot flush | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 2/6 (33.3%) | 0/1 (0%) | 0/8 (0%) | 2/31 (6.5%) | |||||||||
| Hypertension | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) | 0/6 (0%) | 0/1 (0%) | 0/8 (0%) | 1/31 (3.2%) | |||||||||
| Hypotension | 0/2 (0%) | 0/2 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/1 (0%) | 2/8 (25%) | 3/31 (9.7%) | |||||||||
Limitations/Caveats
The study was terminated prematurely for business reasons
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02122146
Other Study ID Numbers:
- B7401001
- 2015-002704-84
First Posted:
Apr 24, 2014
Last Update Posted:
Feb 19, 2018
Last Verified:
Aug 1, 2017