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A Study Of PF-06263507 In Patients With Advanced Solid Tumors

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT01891669
Collaborator
(none)
26
Enrollment
4
Locations
1
Arm
22.7
Actual Duration (Months)
6.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the safety and tolerability at increasing dose levels of PF-06263507 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 :
26 participants
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS
Actual Study Start Date :
Aug 8, 2013
Actual Primary Completion Date :
Jun 29, 2015
Actual Study Completion Date :
Jun 29, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1

Drug: PF-06263507
Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.

Drug: PF-06263507
Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Dose-limiting Toxicities (DLT) [Baseline up to Cycle 2 Day 1 (22 days)]

    DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Secondary Outcome Measures

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade [Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.

  2. Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade [Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.

  3. Number of Participants With Hematological Test Abnormalities in All Cycles. [Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment]

    Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.

  4. Number of Participants With Chemistry Test Abnormalities in All Cycles. [Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment]

    Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.

  5. Number of Participants With Abnormalities in Urine Protein in All Cycles. [Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment]

    Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.

  6. Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria [Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.]

    Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).

  7. Number of Participants With Positive Anti-PF-06263507 Antibody [Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication]

    The number of participants with positive anti-PF-06263507 antibody.

  8. Number of Participants With Best Overall Response (BOR) [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.]

    Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.

  9. Objective Response [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.]

    Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.

  10. Overall Survival [Baseline to death]

    Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.

  11. Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) [Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.]

  12. Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) [Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.]

  13. Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) [Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.]

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 which no standard therapy is available.

  • Performance Status of 0 or 1.

  • Adequate bone marrow, kidney, liver, and heart function.

Exclusion Criteria:

  • Brain metastases requiring steroids.

  • Major surgery or anti-cancer therapy within 4 weeks of study treatment start.

  • Active bacterial, fungal or viral infection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115
2 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
3 Karmanos Cancer Institute Detroit Michigan United States 48201
4 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

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:
NCT01891669
Other Study ID Numbers:
  • B4481001
First Posted:
Jul 3, 2013
Last Update Posted:
Jan 9, 2019
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Pfizer
ADC 5T4
PF-06263507
solid tumors
lung cancer
breast cancer
ovarian cancer
cancer
tumors
neoplasm metastasis
Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
PF-06263507

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Period Title: Overall Study
STARTED 2 2 2 2 2 2 2 6 3 3
COMPLETED 0 1 2 2 2 2 1 2 2 1
NOT COMPLETED 2 1 0 0 0 0 1 4 1 2

Baseline Characteristics

Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg Total
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. Total of all reporting groups
Overall Participants 2 2 2 2 2 2 2 6 3 3 26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
60.5
(2.1)
57
(4.2)
41
(22.6)
60
(7.1)
53.5
(14.8)
62
(36.8)
61.5
(7.8)
65.2
(9.9)
57.7
(5.1)
67.7
(5.9)
59.9
(12.7)
Sex: Female, Male (Count of Participants)
FEMALE
1
50%
1
50%
1
50%
0
0%
1
50%
2
100%
2
100%
4
66.7%
2
66.7%
1
33.3%
15
57.7%
MALE
1
50%
1
50%
1
50%
2
100%
1
50%
0
0%
0
0%
2
33.3%
1
33.3%
2
66.7%
11
42.3%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Dose-limiting Toxicities (DLT)
Description DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame Baseline up to Cycle 2 Day 1 (22 days)

Outcome Measure Data

Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Number [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%
2
66.7%
2. Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Time Frame Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.

Outcome Measure Data

Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Any AEs, Grade 1
1
50%
0
0%
1
50%
2
100%
0
0%
2
100%
1
50%
0
0%
0
0%
0
0%
Any AEs, Grade 2
1
50%
1
50%
1
50%
0
0%
2
100%
0
0%
0
0%
2
33.3%
2
66.7%
1
33.3%
Any AEs, Grade 3
0
0%
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
3
50%
1
33.3%
2
66.7%
Any AEs, Grade 4
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
50%
0
0%
0
0%
0
0%
Any AEs, Grade 5
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%
0
0%
Any AEs, Total
2
100%
2
100%
2
100%
2
100%
2
100%
2
100%
2
100%
6
100%
3
100%
3
100%
3. Secondary Outcome
Title Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Time Frame Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.

Outcome Measure Data

Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Any AEs, Grade 1
1
50%
1
50%
1
50%
2
100%
1
50%
2
100%
2
100%
4
66.7%
1
33.3%
0
0%
Any AEs, Grade 2
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
1
33.3%
2
66.7%
Any AEs, Grade 3
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
1
33.3%
1
33.3%
Any AEs, Grade 4
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Any AEs, Grade 5
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Any AEs, Total
1
50%
1
50%
1
50%
2
100%
1
50%
2
100%
2
100%
6
100%
3
100%
3
100%
4. Secondary Outcome
Title Number of Participants With Hematological Test Abnormalities in All Cycles.
Description Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.
Time Frame Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment

Outcome Measure Data

Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Anemia Grade 1
1
50%
0
0%
1
50%
2
100%
1
50%
2
100%
0
0%
4
66.7%
1
33.3%
2
66.7%
Anemia Grade 2
0
0%
0
0%
1
50%
0
0%
0
0%
0
0%
1
50%
1
16.7%
2
66.7%
1
33.3%
Hemoglobin increased Grade 1
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%
0
0%
Lymphopenia Grade 1
0
0%
0
0%
1
50%
1
50%
0
0%
2
100%
0
0%
0
0%
2
66.7%
2
66.7%
Lymphopenia Grade 2
0
0%
0
0%
0
0%
1
50%
1
50%
0
0%
1
50%
3
50%
0
0%
0
0%
Lymphopenia Grade 3
1
50%
0
0%
0
0%
0
0%
1
50%
0
0%
0
0%
1
16.7%
0
0%
0
0%
Lymphopenia Grade 4
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%
0
0%
Platelets Grade 1
0
0%
0
0%
0
0%
1
50%
1
50%
0
0%
0
0%
3
50%
1
33.3%
0
0%
Platelets Grade 2
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2
33.3%
0
0%
2
66.7%
Platelets Grade 3
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
White blood cells (WBC) Grade 1
0
0%
0
0%
0
0%
0
0%
1
50%
0
0%
0
0%
1
16.7%
0
0%
0
0%
5. Secondary Outcome
Title Number of Participants With Chemistry Test Abnormalities in All Cycles.
Description Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.
Time Frame Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment

Outcome Measure Data

Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Alanine aminotransferase (ALT) Grade 1
0
0%
0
0%
2
100%
0
0%
0
0%
1
50%
1
50%
1
16.7%
2
66.7%
1
33.3%
Alkaline phosphatase Grade 1
0
0%
1
50%
2
100%
1
50%
0
0%
0
0%
1
50%
3
50%
1
33.3%
1
33.3%
Alkaline phosphatase Grade 2
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%
2
66.7%
Alkaline phosphatase Grade 3
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
0
0%
Aspartate aminotransferase (AST) Grade 1
1
50%
1
50%
2
100%
0
0%
1
50%
1
50%
2
100%
4
66.7%
0
0%
1
33.3%
AST Grade 2
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
1
33.3%
2
66.7%
AST Grade 3
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2
66.7%
0
0%
Bilirubin (total) Grade 1
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%
0
0%
Bilirubin (total) Grade 2
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
0
0%
Creatinine Grade 1
0
0%
2
100%
2
100%
2
100%
2
100%
2
100%
2
100%
6
100%
2
66.7%
1
33.3%
Creatinine Grade 2
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
Hypercalcemia Grade 1
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
0
0%
Hypercalcemia Grade 4
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
50%
0
0%
0
0%
0
0%
Hyperglycemia Grade 1
1
50%
1
50%
2
100%
1
50%
2
100%
2
100%
2
100%
5
83.3%
1
33.3%
1
33.3%
Hyperglycemia Grade 2
1
50%
1
50%
0
0%
1
50%
0
0%
0
0%
0
0%
1
16.7%
0
0%
2
66.7%
Hyperkalemia Grade 1
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2
33.3%
0
0%
0
0%
Hypernatremia Grade 1
0
0%
0
0%
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Hypoalbuminemia Grade 1
0
0%
1
50%
1
50%
1
50%
1
50%
2
100%
1
50%
2
33.3%
0
0%
1
33.3%
Hypoalbuminemia Grade 2
1
50%
1
50%
0
0%
0
0%
0
0%
0
0%
1
50%
1
16.7%
3
100%
2
66.7%
Hypocalcemia Grade 1
0
0%
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
2
33.3%
0
0%
1
33.3%
Hypocalcemia Grade 2
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
Hypoglycemia Grade 1
0
0%
0
0%
0
0%
0
0%
0
0%
1
50%
0
0%
0
0%
0
0%
0
0%
Hypokalemia Grade 1
1
50%
1
50%
0
0%
0
0%
0
0%
1
50%
2
100%
3
50%
1
33.3%
0
0%
Hypokalemia Grade 3
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
Hypomagnesemia Grade 1
0
0%
1
50%
2
100%
0
0%
0
0%
0
0%
2
100%
1
16.7%
3
100%
1
33.3%
Hyponatremia Grade 1
1
50%
1
50%
0
0%
0
0%
0
0%
0
0%
1
50%
5
83.3%
3
100%
2
66.7%
Hyponatremia Grade 3
0
0%
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
Hypophosphatemia Grade 2
1
50%
1
50%
0
0%
0
0%
1
50%
0
0%
1
50%
0
0%
0
0%
2
66.7%
Hypophosphatemia Grade3
0
0%
0
0%
0
0%
1
50%
0
0%
0
0%
0
0%
1
16.7%
0
0%
0
0%
6. Secondary Outcome
Title Number of Participants With Abnormalities in Urine Protein in All Cycles.
Description Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.
Time Frame Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment

Outcome Measure Data

Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Urine protein Grade 1
1
50%
0
0%
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Urine protein Grade 2
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
7. Secondary Outcome
Title Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Description Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).
Time Frame Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.

Outcome Measure Data

Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
DBP <50 mm Hg
0
0%
0
0%
1
50%
0
0%
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
SBP maximum increase from baseline >=30 mm Hg
0
0%
0
0%
0
0%
1
50%
0
0%
2
100%
0
0%
0
0%
1
33.3%
0
0%
DBP maximum increase from baseline >=20 mm Hg
0
0%
0
0%
0
0%
0
0%
1
50%
1
50%
0
0%
0
0%
1
33.3%
1
33.3%
SBP maximum decrease from baseline >=30 mm Hg
1
50%
0
0%
1
50%
0
0%
0
0%
0
0%
2
100%
2
33.3%
0
0%
1
33.3%
DBP maximum decrease from baseline >=20 mm Hg
1
50%
0
0%
2
100%
0
0%
1
50%
0
0%
0
0%
3
50%
0
0%
0
0%
8. Secondary Outcome
Title Number of Participants With Positive Anti-PF-06263507 Antibody
Description The number of participants with positive anti-PF-06263507 antibody.
Time Frame Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication

Outcome Measure Data

Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Number [Participants]
1
50%
0
0%
1
50%
1
50%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
9. Secondary Outcome
Title Number of Participants With Best Overall Response (BOR)
Description Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.

Outcome Measure Data

Analysis Population Description
Participants who had received at least one dose of study medication and had a baseline tumor assessment
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
CR
0
0
0
0
0
0
0
0
0
0
PR
0
0
0
0
0
0
0
0
0
0
Stable/No response
1
0
0
0
0
0
0
0
0
1
Objective progression
1
2
1
1
2
2
2
4
3
1
Symptomatic deterioration
0
0
1
1
0
0
0
0
0
0
Early death
0
0
0
0
0
0
0
0
0
0
Interminate
0
0
0
0
0
0
0
2
0
1
10. Secondary Outcome
Title Objective Response
Description Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.
Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.

Outcome Measure Data

Analysis Population Description
Participants who had received at least one dose of study medication and had a baseline tumor assessment
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Number [pariticpants]
0
0
0
0
0
0
0
0
0
0
11. Secondary Outcome
Title Overall Survival
Description Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.
Time Frame Baseline to death

Outcome Measure Data

Analysis Population Description
All enrolled participants
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Number of deaths
0
1
0
0
0
0
0
1
0
1
Number for censored
2
1
2
2
2
2
2
5
3
2
12. Secondary Outcome
Title Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)
Description
Time Frame Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.

Outcome Measure Data

Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Median (Full Range) [hour]
1.07
1.00
2.49
1.01
1.03
1.02
2.49
1.13
1.03
1.22
13. Secondary Outcome
Title Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)
Description
Time Frame Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.

Outcome Measure Data

Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 2 6 3 3
Median (Full Range) [hour]
1.07
4.00
2.53
1.01
6.01
1.02
7.44
4.00
8.00
3.90
14. Secondary Outcome
Title Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)
Description
Time Frame Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.

Outcome Measure Data

Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Arm/Group Title PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
Measure Participants 2 2 2 2 2 2 6 3 3
Median (Full Range) [hour]
36.2
16.0
37.2
51.0
9.99
9.51
8.02
8.13
8.25

Adverse Events

Time Frame Baseline to end of treatment/withdrawal
Adverse Event Reporting Description
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Arm/Group Description PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
All Cause Mortality
PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
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 Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
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 Affected / at Risk (%) # Events
Total 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Cardiac disorders
Atrial fibrillation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Other (Not Including Serious) Adverse Events
PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
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 Affected / at Risk (%) # Events
Total 2/2 (100%) 2/2 (100%) 2/2 (100%) 2/2 (100%) 2/2 (100%) 2/2 (100%) 2/2 (100%) 6/6 (100%) 3/3 (100%) 3/3 (100%)
Blood and lymphatic system disorders
Anaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 1/3 (33.3%)
Coagulopathy 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Leukopenia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Lymphadenopathy 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Thrombocytopenia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 2/6 (33.3%) 1/3 (33.3%) 3/3 (100%)
Cardiac disorders
Tachycardia 1/2 (50%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Eye disorders
Corneal deposits 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Dry eye 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 1/6 (16.7%) 2/3 (66.7%) 2/3 (66.7%)
Eye pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 2/3 (66.7%) 1/3 (33.3%)
Eye pruritus 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Eye swelling 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Keratitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Keratopathy 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Lacrimation decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Lacrimation increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/3 (0%)
Photophobia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 3/6 (50%) 2/3 (66.7%) 2/3 (66.7%)
Vision blurred 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 2/6 (33.3%) 1/3 (33.3%) 1/3 (33.3%)
Vitreous floaters 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 1/3 (33.3%)
Gastrointestinal disorders
Abdominal distension 1/2 (50%) 1/2 (50%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 2/3 (66.7%)
Abdominal pain 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Abdominal pain upper 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Ascites 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 1/3 (33.3%) 1/3 (33.3%)
Constipation 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 1/6 (16.7%) 1/3 (33.3%) 0/3 (0%)
Diarrhoea 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 1/3 (33.3%)
Dry mouth 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/2 (50%) 1/6 (16.7%) 0/3 (0%) 1/3 (33.3%)
Dyspepsia 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Mouth ulceration 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Nausea 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 2/2 (100%) 3/6 (50%) 0/3 (0%) 1/3 (33.3%)
Oral mucosal erythema 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Retching 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Stomatitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Vomiting 1/2 (50%) 0/2 (0%) 1/2 (50%) 1/2 (50%) 1/2 (50%) 1/2 (50%) 1/2 (50%) 1/6 (16.7%) 0/3 (0%) 1/3 (33.3%)
General disorders
Application site irritation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Chest discomfort 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Chest pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Chills 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 2/3 (66.7%) 1/3 (33.3%)
Fatigue 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/2 (50%) 1/2 (50%) 1/2 (50%) 1/2 (50%) 4/6 (66.7%) 2/3 (66.7%) 1/3 (33.3%)
Inflammation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Non-cardiac chest pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/2 (50%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Oedema 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Oedema peripheral 1/2 (50%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 1/3 (33.3%) 1/3 (33.3%)
Peripheral swelling 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Pyrexia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/3 (0%)
Hepatobiliary disorders
Hepatobiliary disease 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Infections and infestations
Conjunctivitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 1/3 (33.3%)
Device related infection 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Fungal skin infection 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Oral infection 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Sinusitis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Upper respiratory tract infection 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Urinary tract infection 0/2 (0%) 1/2 (50%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Injury, poisoning and procedural complications
Fall 2/2 (100%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Investigations
Alanine aminotransferase increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 1/3 (33.3%)
Aspartate aminotransferase increased 1/2 (50%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 2/3 (66.7%) 2/3 (66.7%)
Blood alkaline phosphatase increased 1/2 (50%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Blood bilirubin increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Blood creatinine increased 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 2/6 (33.3%) 0/3 (0%) 0/3 (0%)
Blood lactate dehydrogenase increased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Blood urea increased 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Cardiac murmur 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Ejection fraction decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Troponin I increased 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Urine analysis abnormal 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Waist circumference increased 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Weight decreased 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Metabolism and nutrition disorders
Decreased appetite 1/2 (50%) 0/2 (0%) 1/2 (50%) 1/2 (50%) 0/2 (0%) 1/2 (50%) 1/2 (50%) 2/6 (33.3%) 2/3 (66.7%) 1/3 (33.3%)
Dehydration 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 1/3 (33.3%)
Hypercalcaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Hypoalbuminaemia 1/2 (50%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Hypoglycaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Hypokalaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Hypomagnesaemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 3/3 (100%) 0/3 (0%)
Hyponatraemia 1/2 (50%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/3 (0%)
Hypophosphataemia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Back pain 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Flank pain 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Muscular weakness 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Musculoskeletal chest pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/3 (0%)
Neck pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Pain in extremity 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Pain in jaw 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Nervous system disorders
Dizziness 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 2/6 (33.3%) 0/3 (0%) 0/3 (0%)
Dysaesthesia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Dysgeusia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/3 (0%)
Headache 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 2/6 (33.3%) 1/3 (33.3%) 0/3 (0%)
Lethargy 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Neuropathy peripheral 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Peripheral sensory neuropathy 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Restless legs syndrome 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Psychiatric disorders
Agitation 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Anxiety 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Confusional state 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Insomnia 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Renal and urinary disorders
Haematuria 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Obstructive uropathy 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Pollakiuria 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 1/2 (50%) 1/2 (50%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/3 (0%)
Dysphonia 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Dyspnoea 2/2 (100%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 2/6 (33.3%) 0/3 (0%) 0/3 (0%)
Dyspnoea exertional 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Epistaxis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 1/3 (33.3%)
Haemoptysis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Hiccups 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Nasal congestion 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Oropharyngeal pain 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Productive cough 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Sputum discoloured 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Wheezing 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Skin and subcutaneous tissue disorders
Decubitus ulcer 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Dry skin 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)
Night sweats 0/2 (0%) 1/2 (50%) 0/2 (0%) 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Onycholysis 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Pruritus 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Vascular disorders
Embolism 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%)
Flushing 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%)
Hot flush 1/2 (50%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%)
Hypotension 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%)

Limitations/Caveats

This study was terminated prematurely before treatment in Part 2 started due to a business-related decision.

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 18007181021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01891669
Other Study ID Numbers:
  • B4481001
First Posted:
Jul 3, 2013
Last Update Posted:
Jan 9, 2019
Last Verified:
Dec 1, 2018