PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
Stopped early · Phase 2
Conditions studied: Metastatic Renal Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT01441414
- Run by
- Pfizer
- People needed
- 18
- Starts
- 2011-11-21
- Expected to finish
- 2014-03-27
- Last updated by the study team
- 2019-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
- Arizona Oncology Associates, PC-HOPE — Tucson, Arizona, United States
- Rocky Mountain Cancer Centers — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers — Boulder, Colorado, United States
- Rocky Mountain Cancer Centers — Centennial, Colorado, United States
- Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
- Rocky Mountain Cancer Centers — Littleton, Colorado, United States
- Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States
- Rocky Mountain Cancer Centers — Longmont, Colorado, United States
- Rocky Mountain Cancer Centers — Parker, Colorado, United States
- Rocky Mountain Cancer Centers — Pueblo, Colorado, United States
- Rocky Mountain Cancer Centers — Thornton, Colorado, United States
- Nebraska Methodist Hospital — Omaha, Nebraska, United States
- Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Regional Cancer Care-Durham — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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