Renal Cell Carcinoma
|Closed||Metastatic Renal Cell Carcinoma||Phase II||NCT01441414|
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.
- 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
- Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain the core platform antibody as PF 04856884
- 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.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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