PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01441414
First received: August 26, 2011
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
To evaluate the combination of PF-04856884 (CVX-060) in combination with axitinib in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Renal Cell Carcinoma |
Biological: PF-04856884 Drug: AG-013736 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: 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 Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Part I: Safety profile characterized by type, grade and frequency of all adverse events, [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Part II: Progression free survival (PFS) in adult patients with previously treated mRCC. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); Safety profile characterized by type, grade and frequency of all adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Overall response rate (ORR) in mRCC patients treated with PF-04856884 in combination with AG013736 vs. AG013736 alone. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Duration of response in mRCC patients treated with PF-04856884 in combination with AG013736 vs. AG013736 alone. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters [Tmax (Time when maximum plasma concentration is reached)] will be estimated using noncompartmental methods. [ Time Frame: 0, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of study (expected ~6 months) ] [ Designated as safety issue: No ]
- To determine if patients treated with PF 04856884 develop anti drug antibodies during their treatment with PF 04856884 [ Time Frame: 0 and 360 hours post dose and end of study (expected ~6 months) ] [ Designated as safety issue: No ]
- Individual concentration/time data as well as change from baseline/time will be assessed for circulating pharmacodynamic and exploratory biomarkers. [ Time Frame: 0, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of study (expected ~6 months) ] [ Designated as safety issue: No ]
- Part II: Progression free survival (PFS) in adult patients with previously treated mRCC as measured by an independent radiological assessment. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival (OS) at two years in patients treated in protocol B1131004. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters [Cmax (Peak plasma concentration)] will be estimated using noncompartmental methods. [ Time Frame: 0, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of study (expected ~6 months) ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters [Cmin (Minimum drug concentration)] will be estimated using noncompartmental methods. [ Time Frame: 0, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of study (expected ~6 months) ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ARM A
PF-04856884 in combination with AG-013736
|
Biological: PF-04856884
15 mg/kg/week intravenously [IV] until toxicity or disease progression
|
|
Active Comparator: ARM B
AG-013736 alone
|
Drug: AG-013736
5 mg PO BID
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441414
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Scottsdale, Arizona, United States, 85258 | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85704 | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85710 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Aurora, Colorado, United States, 80012 | |
| Pfizer Investigational Site | |
| Boulder, Colorado, United States, 80303 | |
| Pfizer Investigational Site | |
| Colorado Springs, Colorado, United States, 80907 | |
| Pfizer Investigational Site | |
| Colorado Springs, Colorado, United States, 80909 | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80218 | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80220 | |
| Pfizer Investigational Site | |
| Lakewood, Colorado, United States, 80228 | |
| Pfizer Investigational Site | |
| Littleton, Colorado, United States, 80120-4413 | |
| Pfizer Investigational Site | |
| Lone Tree, Colorado, United States, 80124 | |
| Pfizer Investigational Site | |
| Longmont, Colorado, United States, 80501 | |
| Pfizer Investigational Site | |
| Parker, Colorado, United States, 80138 | |
| Pfizer Investigational Site | |
| Pueblo, Colorado, United States, 81008 | |
| Pfizer Investigational Site | |
| Thornton, Colorado, United States, 80260 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Henderson, Nevada, United States, 89014 | |
| Pfizer Investigational Site | |
| Henderson, Nevada, United States, 89074 | |
| Pfizer Investigational Site | |
| Henderson, Nevada, United States, 89052 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89128 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89148 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27704 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76177 | |
| Pfizer Investigational Site | |
| Tyler, Texas, United States, 75702 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98109 | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98195 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Brno, Czech Republic, 65653 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01441414 History of Changes |
| Other Study ID Numbers: | B1131004 |
| Study First Received: | August 26, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
CVX-060 PF-04856884 AG-013736 axitinib mRCC |
metastatic renal cell cancer second line anti-angiogenic Ang-2 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013