- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01441414
PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brno, Czechia, 65653
- Masarykuv onkologicky ustav
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Arizona
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Scottsdale, Arizona, United States, 85258
- Pinnacle Oncology Hematology
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Tucson, Arizona, United States, 85704
- Arizona Oncology Associates, PC - HOPE
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Tucson, Arizona, United States, 85710
- Arizona Oncology Associates, PC-Hope
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Colorado
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Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers
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Boulder, Colorado, United States, 80303
- Rocky Mountain Cancer Centers
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Centennial, Colorado, United States, 80112
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, United States, 80909
- Rocky Mountain Cancer Centers
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers
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Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers
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Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers
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Littleton, Colorado, United States, 80120-4413
- Rocky Mountain Cancer Centers
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Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers
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Longmont, Colorado, United States, 80501
- Rocky Mountain Cancer Centers
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Parker, Colorado, United States, 80138
- Rocky Mountain Cancer Centers
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Pueblo, Colorado, United States, 81008
- Rocky Mountain Cancer Centers
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Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Hospital
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Nevada
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Henderson, Nevada, United States, 89074
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, United States, 89014
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, United States, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, United States, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada
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North Carolina
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Durham, North Carolina, United States, 27704
- Regional Cancer Care-Durham
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Texas
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Tyler, Texas, United States, 75702
- Texas Oncology-Tyler
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Washington
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Seattle, Washington, United States, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ARM A
PF-04856884 in combination with AG-013736
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15 mg/kg/week intravenously [IV] until toxicity or disease progression
5 mg PO BID
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Active Comparator: ARM B
AG-013736 alone
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5 mg PO BID
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).
Time Frame: 4 months
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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). |
4 months
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Number of Participants With Serious Adverse Events (SAEs) in Part I
Time Frame: 4 months
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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.
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4 months
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Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II
Time Frame: 3 years
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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).
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Non-serious AEs and SAEs
Time Frame: 3 years
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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).
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3 years
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Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.
Time Frame: 4 months
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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.
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4 months
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Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone
Time Frame: 3 years
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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).
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3 years
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Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)
Time Frame: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.
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Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Cmax (Observed Peak Serum PF-04856884 Concentration)
Time Frame: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.
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Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Cmin (Trough PF-04856884 Serum Concentration)
Time Frame: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.
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Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
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Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive
Time Frame: 0 and 360 hours post dose and end of study
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Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.
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0 and 360 hours post dose and end of study
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Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment
Time Frame: 3 years
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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).
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3 years
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Overall Survival (OS) at 2 Years
Time Frame: 5 years
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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.
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5 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Axitinib
Other Study ID Numbers
- B1131004
- 2011-002190-33 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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