Status:
TERMINATED
PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
Lead Sponsor:
Pfizer
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. a...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01441414
Start Date
November 21 2011
End Date
March 27 2014
Last Update
January 8 2019
Active Locations (29)
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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