PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT01441414
Collaborator
(none)
18
29
2
28.2
0.6
0
Study Details
Study Description
Brief Summary
To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and venous thrombotic events (VTEs) were reported in patients treated in Part I.
Study Design
Study Type:
Interventional
Actual Enrollment
:
18 participants
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PHASE II TRIAL OF PF-04856884 (CVX-060), A SELECTIVE ANGIOPOIETIN-2 (ANG-2) INHIBITOR IN COMBINATION WITH AG-013736 (AXITINIB) IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC RENAL CELL CARCINOMA
Actual Study Start Date
:
Nov 21, 2011
Actual Primary Completion Date
:
Mar 27, 2014
Actual Study Completion Date
:
Mar 27, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ARM A PF-04856884 in combination with AG-013736 |
Biological: PF-04856884
15 mg/kg/week intravenously [IV] until toxicity or disease progression
Drug: Axitinib (AG-013736)
5 mg PO BID
|
| Active Comparator: ARM B AG-013736 alone |
Drug: Axitinib (AG-013736)
5 mg PO BID
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall). [4 months]
Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
- Number of Participants With Serious Adverse Events (SAEs) in Part I [4 months]
Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE.
- Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II [3 years]
PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date - the date of randomization +1).
Secondary Outcome Measures
- Number of Participants With Non-serious AEs and SAEs [3 years]
Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
- Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone. [4 months]
ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR.
- Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone [3 years]
DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR - first CR or PR that is subsequently confirmed +1).
- Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached) [Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment]
Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.
- Cmax (Observed Peak Serum PF-04856884 Concentration) [Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment]
Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.
- Cmin (Trough PF-04856884 Serum Concentration) [Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment]
Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.
- Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive [0 and 360 hours post dose and end of study]
Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.
- Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment [3 years]
PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date - the date of randomization +1).
- Overall Survival (OS) at 2 Years [5 years]
OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adult male or female patients with histologically or cytologically confirmed renal cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis
-
Evidence of unidimensionally measurable disease
-
Prior therapy: Part I: Having received 1 to 3 prior systemic regimens for treatment of mRCC
-
Part II: Evidence of disease progression following 1 prior regimen administered as 1st line therapy for mRCC. The prior regimen must have contained one of the following: VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF [Vascular Endothelial Growth Factor] compounds, such as bevacizumab
-
adequate bone marrow, liver and renal function
Exclusion Criteria:
Part I:
- Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain the core platform antibody as PF 04856884
Part II:
-
Prior AG 013736 therapy, more than one systemic first-line regimen for the treatment of mRCC and prior treatment with compounds which contain the core platform antibody as PF 04856884
-
major surgery <4 weeks or radiation therapy <2 weeks prior to start of therapy
-
clinically significant gastrointestinal abnormalities
-
current use or anticipated need for drugs that are known potent CYP3A4 inhibitors and drugs that are known CYP3A4 or CYP1A2 inducers
-
history of bleeding diathesis or coagulopathy
-
Grade 3 or greater hemorrhage from any cause <4 weeks prior to screening;
-
hemoptysis >½ teaspoon of blood per day within 2 weeks prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Oncology Hematology | Scottsdale | Arizona | United States | 85258 |
| 2 | Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | United States | 85704 |
| 3 | Arizona Oncology Associates, PC-HOPE | Tucson | Arizona | United States | 85710 |
| 4 | Rocky Mountain Cancer Centers | Aurora | Colorado | United States | 80012 |
| 5 | Rocky Mountain Cancer Centers | Boulder | Colorado | United States | 80303 |
| 6 | Rocky Mountain Cancer Centers | Centennial | Colorado | United States | 80112 |
| 7 | Rocky Mountain Cancer Centers | Colorado Springs | Colorado | United States | 80907 |
| 8 | Rocky Mountain Cancer Centers | Colorado Springs | Colorado | United States | 80909 |
| 9 | Rocky Mountain Cancer Centers | Denver | Colorado | United States | 80218 |
| 10 | Rocky Mountain Cancer Centers | Denver | Colorado | United States | 80220 |
| 11 | Rocky Mountain Cancer Centers | Lakewood | Colorado | United States | 80228 |
| 12 | Rocky Mountain Cancer Centers | Littleton | Colorado | United States | 80120-4413 |
| 13 | Rocky Mountain Cancer Centers | Lone Tree | Colorado | United States | 80124 |
| 14 | Rocky Mountain Cancer Centers | Longmont | Colorado | United States | 80501 |
| 15 | Rocky Mountain Cancer Centers | Parker | Colorado | United States | 80138 |
| 16 | Rocky Mountain Cancer Centers | Pueblo | Colorado | United States | 81008 |
| 17 | Rocky Mountain Cancer Centers | Thornton | Colorado | United States | 80260 |
| 18 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68114 |
| 19 | Comprehensive Cancer Centers of Nevada | Henderson | Nevada | United States | 89014 |
| 20 | Comprehensive Cancer Centers of Nevada | Henderson | Nevada | United States | 89052 |
| 21 | Comprehensive Cancer Centers of Nevada | Henderson | Nevada | United States | 89074 |
| 22 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89128 |
| 23 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89148 |
| 24 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
| 25 | Regional Cancer Care-Durham | Durham | North Carolina | United States | 27704 |
| 26 | Texas Oncology-Tyler | Tyler | Texas | United States | 75702 |
| 27 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
| 28 | University of Washington Medical Center | Seattle | Washington | United States | 98195 |
| 29 | Masarykuv onkologicky ustav | Brno | Czechia | 65653 |
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:
NCT01441414
Other Study ID Numbers:
- B1131004
- 2011-002190-33
First Posted:
Sep 27, 2011
Last Update Posted:
Jan 8, 2019
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This multicenter, open-label study consisted of a safety lead in stage (Part I) followed by a randomized Phase 2 stage (Part II). A total of 18 participants were screened and assigned to treatment in Part I, with 3 participants completing Part I of the study. At the completion of Part I, all 18 participants had discontinued combined treatment. |
|---|---|
| Pre-assignment Detail | During Part I, 3 to 4 participants were initially treated with the study drug combination in 28-day cycles. If no participants experienced Cycle 1 dose limiting toxicities (DLTs), another 6 to 9 participants were treated at this dose level. Part II of the study was to be initiated if Cycle 1 DLTs were observed in <33% in at least 12 participants. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Period Title: Overall Study | |
| STARTED | 18 |
| COMPLETED | 3 |
| NOT COMPLETED | 15 |
Baseline Characteristics
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Overall Participants | 18 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
63.2
(10.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
22.2%
|
| Male |
14
77.8%
|
Outcome Measures
| Title | Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall). |
|---|---|
| Description | Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Time Frame | 4 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. |
| Arm/Group Title | All-causality CTCAE Grade 3 | All-causality CTCAE Grade 4 | All-causality CTCAE Grade 5 | Treatment-related CTCAE Grade 3 | Treatment-related CTCAE Grade 4 | Treatment-related CTCAE Grade 5 | All-causality Overall | Treatment-related Overall |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Incidence and severity of all-causality CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. | Incidence and severity of all-causality CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. | Incidence and severity of all-causality CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. | Incidence and severity of treatment-related CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. | Incidence and severity of treatment-related CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. | Incidence and severity of treatment-related CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. | Incidence and severity of all-causality CTCAE Grades 3, 4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. | Incidence and severity of treatment-related CTCAE Grades 3,4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Measure Participants | 18 | 18 | 18 | 18 | 18 | 18 | 18 | 18 |
| Anaemia |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
4
NaN
|
2
NaN
|
| Leukocytosis |
2
11.1%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Pericardial effusion |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Hyperthyroidism |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Hypothyroidism |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Vision blurred |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Abdominal pain |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Constipation |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
8
NaN
|
2
NaN
|
| Diarrhoea |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
10
NaN
|
9
NaN
|
| Dry mouth |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
3
NaN
|
NA
NaN
|
| Gastritis |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Nausea |
1
5.6%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
11
NaN
|
7
NaN
|
| Oral pain |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Stomatitis |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Toothache |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Vomiting |
1
5.6%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
10
NaN
|
6
NaN
|
| Asthenia |
1
5.6%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Fatigue |
5
27.8%
|
0
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
0
NaN
|
11
NaN
|
8
NaN
|
| Oedema peripheral |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Pneumonia |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Upper respiratory tract infection |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Urinary tract infection |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
3
NaN
|
NA
NaN
|
| Blood creatinine increased |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
3
NaN
|
NA
NaN
|
| Weight decreased |
2
11.1%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
4
NaN
|
4
NaN
|
| Decreased appetite |
1
5.6%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
12
NaN
|
11
NaN
|
| Dehydration |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
3
NaN
|
2
NaN
|
| Hypercalcaemia |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Hypokalaemia |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Hyponatraemia |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Hypovolaemia |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Arthralgia |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
3
NaN
|
NA
NaN
|
| Back pain |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
5
NaN
|
NA
NaN
|
| Muscle spasms |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Muscular weakness |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Myalgia |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Cerebrovascular accident |
1
5.6%
|
1
NaN
|
0
NaN
|
1
NaN
|
1
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Dizziness |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
4
NaN
|
NA
NaN
|
| Headache |
1
5.6%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
3
NaN
|
2
NaN
|
| Migraine |
1
5.6%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Neuropathy peripheral |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Depression |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
3
NaN
|
NA
NaN
|
| Insomnia |
1
5.6%
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
7
NaN
|
2
NaN
|
| Proteinuria |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
3
NaN
|
3
NaN
|
| Cough |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
7
NaN
|
NA
NaN
|
| Dysphonia |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
5
NaN
|
5
NaN
|
| Dyspnoea |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
6
NaN
|
NA
NaN
|
| Hypoxia |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Pleural effusion |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
3
NaN
|
NA
NaN
|
| Pulmonary embolism |
1
5.6%
|
1
NaN
|
0
NaN
|
1
NaN
|
1
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Night sweats |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
2
NaN
|
NA
NaN
|
| Palmar-plantar erythrodysaesthesia |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
| Hot flush |
0
0%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
3
NaN
|
NA
NaN
|
| Hypertension |
5
27.8%
|
0
NaN
|
0
NaN
|
4
NaN
|
0
NaN
|
0
NaN
|
10
NaN
|
9
NaN
|
| Hypotension |
1
5.6%
|
0
NaN
|
0
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
4
NaN
|
NA
NaN
|
| Title | Number of Participants With Serious Adverse Events (SAEs) in Part I |
|---|---|
| Description | Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE. |
| Time Frame | 4 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. |
| Arm/Group Title | All-causality CTCAE Grade 2 | All-causality CTCAE Grade 3 | All-causality CTCAE Grade 4 | All-causality CTCAE Grade 5 |
|---|---|---|---|---|
| Arm/Group Description | Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 2 TEAEs are presented | Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 3 TEAEs are presented | Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 4 TEAEs are presented | Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 5 TEAEs are presented |
| Measure Participants | 18 | 18 | 18 | 18 |
| Pneumonia |
1
5.6%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Pleural effusion |
1
5.6%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Ileus |
1
5.6%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Abdominal pain |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Ascites |
1
5.6%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Lung infection |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Back pain |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Musculoskeletal chest pain |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Convulsion |
1
5.6%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Embolism |
1
5.6%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Hyponatraemia |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Dyspnoea |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Hypotension |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Cerebrovascular accident |
0
0%
|
1
NaN
|
1
NaN
|
0
NaN
|
| Migraine |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Meningioma |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Hypovolaemia |
1
5.6%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Pulmonary embolism |
0
0%
|
1
NaN
|
1
NaN
|
0
NaN
|
| Pericardial effusion |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
| Gastrointestinal disorder |
0
0%
|
0
NaN
|
0
NaN
|
1
NaN
|
| Chest discomfort |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Hypertension |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Title | Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II |
|---|---|
| Description | PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date - the date of randomization +1). |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary efficacy endpoint of estimating median PFS in Part II was not assessed due to early termination of the study. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 0 |
| Title | Number of Participants With Non-serious AEs and SAEs |
|---|---|
| Description | Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This endpoint was not assessed due to the early termination of the study. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 0 |
| Title | Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone. |
|---|---|
| Description | ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR. |
| Time Frame | 4 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 18 |
| Complete response (CR) |
0
0%
|
| Partial response (PR) |
11.1
61.7%
|
| ORR (CR + PR) |
11.1
61.7%
|
| Title | Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone |
|---|---|
| Description | DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR - first CR or PR that is subsequently confirmed +1). |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This endpoint was not assessed due to the early termination of the study. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 0 |
| Title | Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached) |
|---|---|
| Description | Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods. |
| Time Frame | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 18 |
| CYCLE1/DAY1 |
2.000
(1.6450)
|
| CYCLE1/DAY22 |
3.000
(2.1122)
|
| Title | Cmax (Observed Peak Serum PF-04856884 Concentration) |
|---|---|
| Description | Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods. |
| Time Frame | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 18 |
| CYCLE1/DAY1 |
337100
(76245)
|
| CYCLE1/DAY22 |
531400
(154780)
|
| Title | Cmin (Trough PF-04856884 Serum Concentration) |
|---|---|
| Description | Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods. |
| Time Frame | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 18 |
| CYCLE1/DAY1 |
932.7
(3499.1)
|
| CYCLE1/DAY22 |
168900
(84507)
|
| Title | Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive |
|---|---|
| Description | Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884. |
| Time Frame | 0 and 360 hours post dose and end of study |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 18 |
| Measure ADA samples | 91 |
| Number [ADA samples] |
8
|
| Title | Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment |
|---|---|
| Description | PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date - the date of randomization +1). |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This endpoint of estimating median PFS was not assessed due to early termination of the study. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 0 |
| Title | Overall Survival (OS) at 2 Years |
|---|---|
| Description | OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This endpoint was not assessed due to the early termination of the study. |
| Arm/Group Title | PF-04856884 + AG-013736 |
|---|---|
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Measure Participants | 0 |
Adverse Events
| Time Frame | From the day the first dose of the investigational product was administered up to 1 year. | |
|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. | |
| Arm/Group Title | PF-04856884 + AG-013736 | |
| Arm/Group Description | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). | |
All Cause Mortality |
||
| PF-04856884 + AG-013736 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| PF-04856884 + AG-013736 | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/18 (66.7%) | |
| Cardiac disorders | ||
| Pericardial effusion | 1/18 (5.6%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/18 (5.6%) | |
| Ascites | 1/18 (5.6%) | |
| Gastrointestinal disorder | 1/18 (5.6%) | |
| Ileus | 1/18 (5.6%) | |
| General disorders | ||
| Chest discomfort | 1/18 (5.6%) | |
| Infections and infestations | ||
| Lung infection | 1/18 (5.6%) | |
| Pneumonia | 2/18 (11.1%) | |
| Metabolism and nutrition disorders | ||
| Hyponatraemia | 1/18 (5.6%) | |
| Hypovolaemia | 1/18 (5.6%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 1/18 (5.6%) | |
| Musculoskeletal chest pain | 1/18 (5.6%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Meningioma | 1/18 (5.6%) | |
| Nervous system disorders | ||
| Cerebrovascular accident | 2/18 (11.1%) | |
| Convulsion | 1/18 (5.6%) | |
| Migraine | 1/18 (5.6%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnoea | 1/18 (5.6%) | |
| Pleural effusion | 2/18 (11.1%) | |
| Pulmonary embolism | 2/18 (11.1%) | |
| Vascular disorders | ||
| Embolism | 1/18 (5.6%) | |
| Hypertension | 1/18 (5.6%) | |
| Hypotension | 1/18 (5.6%) | |
Other (Not Including Serious) Adverse Events |
||
| PF-04856884 + AG-013736 | ||
| Affected / at Risk (%) | # Events | |
| Total | 18/18 (100%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 4/18 (22.2%) | |
| Leukocytosis | 2/18 (11.1%) | |
| Thrombocytopenia | 1/18 (5.6%) | |
| Cardiac disorders | ||
| Angina pectoris | 1/18 (5.6%) | |
| Pericardial effusion | 1/18 (5.6%) | |
| Sinus tachycardia | 1/18 (5.6%) | |
| Ear and labyrinth disorders | ||
| Tinnitus | 1/18 (5.6%) | |
| Endocrine disorders | ||
| Hyperthyroidism | 2/18 (11.1%) | |
| Hypothyroidism | 2/18 (11.1%) | |
| Eye disorders | ||
| Eye pain | 1/18 (5.6%) | |
| Vision blurred | 3/18 (16.7%) | |
| Visual impairment | 1/18 (5.6%) | |
| Vitreous floaters | 1/18 (5.6%) | |
| Gastrointestinal disorders | ||
| Abdominal discomfort | 1/18 (5.6%) | |
| Abdominal distension | 1/18 (5.6%) | |
| Abdominal pain | 2/18 (11.1%) | |
| Aphthous stomatitis | 1/18 (5.6%) | |
| Ascites | 1/18 (5.6%) | |
| Constipation | 8/18 (44.4%) | |
| Diarrhoea | 10/18 (55.6%) | |
| Dry mouth | 3/18 (16.7%) | |
| Eructation | 1/18 (5.6%) | |
| Faecal incontinence | 1/18 (5.6%) | |
| Gastritis | 2/18 (11.1%) | |
| Gastrooesophageal reflux disease | 1/18 (5.6%) | |
| Glossodynia | 1/18 (5.6%) | |
| Nausea | 11/18 (61.1%) | |
| Oral pain | 2/18 (11.1%) | |
| Stomatitis | 2/18 (11.1%) | |
| Toothache | 2/18 (11.1%) | |
| Vomiting | 10/18 (55.6%) | |
| General disorders | ||
| Asthenia | 2/18 (11.1%) | |
| Chest pain | 1/18 (5.6%) | |
| Chills | 1/18 (5.6%) | |
| Fatigue | 11/18 (61.1%) | |
| Inflammation | 1/18 (5.6%) | |
| Localised oedema | 1/18 (5.6%) | |
| Mucosal inflammation | 1/18 (5.6%) | |
| Oedema | 1/18 (5.6%) | |
| Oedema peripheral | 5/18 (27.8%) | |
| Pain | 1/18 (5.6%) | |
| Pyrexia | 1/18 (5.6%) | |
| Hepatobiliary disorders | ||
| Cholecystitis | 1/18 (5.6%) | |
| Hepatic cyst | 1/18 (5.6%) | |
| Immune system disorders | ||
| Hypersensitivity | 1/18 (5.6%) | |
| Seasonal allergy | 1/18 (5.6%) | |
| Infections and infestations | ||
| Bronchitis | 1/18 (5.6%) | |
| Bronchopulmonary aspergillosis | 1/18 (5.6%) | |
| Candida infection | 1/18 (5.6%) | |
| Cellulitis | 1/18 (5.6%) | |
| Cystitis | 1/18 (5.6%) | |
| Ear infection | 1/18 (5.6%) | |
| Herpes zoster | 1/18 (5.6%) | |
| Otitis media | 1/18 (5.6%) | |
| Peritonitis | 1/18 (5.6%) | |
| Tooth infection | 1/18 (5.6%) | |
| Upper respiratory tract infection | 2/18 (11.1%) | |
| Urinary tract infection | 3/18 (16.7%) | |
| Injury, poisoning and procedural complications | ||
| Procedural pain | 1/18 (5.6%) | |
| Tooth fracture | 1/18 (5.6%) | |
| Investigations | ||
| Blood creatinine increased | 3/18 (16.7%) | |
| Blood thyroid stimulating hormone increased | 1/18 (5.6%) | |
| Coagulation time prolonged | 1/18 (5.6%) | |
| Haptoglobin increased | 1/18 (5.6%) | |
| Neutrophil count abnormal | 1/18 (5.6%) | |
| Weight decreased | 4/18 (22.2%) | |
| White blood cell count abnormal | 1/18 (5.6%) | |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 12/18 (66.7%) | |
| Dehydration | 3/18 (16.7%) | |
| Hypercalcaemia | 2/18 (11.1%) | |
| Hypercholesterolaemia | 1/18 (5.6%) | |
| Hyperglycaemia | 1/18 (5.6%) | |
| Hypoalbuminaemia | 1/18 (5.6%) | |
| Hypocalcaemia | 1/18 (5.6%) | |
| Hypoglycaemia | 1/18 (5.6%) | |
| Hypokalaemia | 2/18 (11.1%) | |
| Hypomagnesaemia | 1/18 (5.6%) | |
| Hyponatraemia | 1/18 (5.6%) | |
| Hypophosphataemia | 1/18 (5.6%) | |
| Hypovolaemia | 1/18 (5.6%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 3/18 (16.7%) | |
| Back pain | 5/18 (27.8%) | |
| Groin pain | 1/18 (5.6%) | |
| Muscle spasms | 2/18 (11.1%) | |
| Muscular weakness | 2/18 (11.1%) | |
| Musculoskeletal pain | 1/18 (5.6%) | |
| Myalgia | 2/18 (11.1%) | |
| Neck pain | 1/18 (5.6%) | |
| Pain in extremity | 1/18 (5.6%) | |
| Pain in jaw | 1/18 (5.6%) | |
| Nervous system disorders | ||
| Cognitive disorder | 1/18 (5.6%) | |
| Depressed level of consciousness | 1/18 (5.6%) | |
| Dizziness | 4/18 (22.2%) | |
| Dysgeusia | 1/18 (5.6%) | |
| Headache | 3/18 (16.7%) | |
| Hypoaesthesia | 1/18 (5.6%) | |
| Lethargy | 1/18 (5.6%) | |
| Memory impairment | 1/18 (5.6%) | |
| Migraine | 2/18 (11.1%) | |
| Neuropathy peripheral | 2/18 (11.1%) | |
| Somnolence | 1/18 (5.6%) | |
| Syncope | 1/18 (5.6%) | |
| Psychiatric disorders | ||
| Anxiety | 1/18 (5.6%) | |
| Confusional state | 1/18 (5.6%) | |
| Depression | 3/18 (16.7%) | |
| Flat affect | 1/18 (5.6%) | |
| Insomnia | 7/18 (38.9%) | |
| Restlessness | 1/18 (5.6%) | |
| Sleep disorder | 1/18 (5.6%) | |
| Renal and urinary disorders | ||
| Nocturia | 1/18 (5.6%) | |
| Proteinuria | 3/18 (16.7%) | |
| Urinary retention | 1/18 (5.6%) | |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia | 1/18 (5.6%) | |
| Scrotal oedema | 1/18 (5.6%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 7/18 (38.9%) | |
| Dysphonia | 5/18 (27.8%) | |
| Dyspnoea | 6/18 (33.3%) | |
| Dyspnoea exertional | 1/18 (5.6%) | |
| Epistaxis | 1/18 (5.6%) | |
| Haemoptysis | 1/18 (5.6%) | |
| Hypoxia | 2/18 (11.1%) | |
| Oropharyngeal pain | 1/18 (5.6%) | |
| Pleural effusion | 2/18 (11.1%) | |
| Rhinalgia | 1/18 (5.6%) | |
| Skin and subcutaneous tissue disorders | ||
| Erythema | 1/18 (5.6%) | |
| Nail disorder | 1/18 (5.6%) | |
| Night sweats | 2/18 (11.1%) | |
| Onychalgia | 1/18 (5.6%) | |
| Palmar-plantar erythrodysaesthesia syndrome | 2/18 (11.1%) | |
| Pruritus | 1/18 (5.6%) | |
| Rash | 1/18 (5.6%) | |
| Skin disorder | 1/18 (5.6%) | |
| Urticaria | 1/18 (5.6%) | |
| Vascular disorders | ||
| Embolism | 1/18 (5.6%) | |
| Hot flush | 3/18 (16.7%) | |
| Hypertension | 9/18 (50%) | |
| Hypotension | 4/18 (22.2%) | |
Limitations/Caveats
On 06 Nov 2012, based on Part I safety findings and due to strategic considerations, Pfizer decided not to open enrolment onto Part II of the study and terminated the study. For primary OM, AEs reported in ≥2 participants overall are presented.
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:
NCT01441414
Other Study ID Numbers:
- B1131004
- 2011-002190-33
First Posted:
Sep 27, 2011
Last Update Posted:
Jan 8, 2019
Last Verified:
Dec 1, 2018