PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma

• Status: Terminated
• Trial end date: 2014-03-27
• Target enrollment: 0
• Participant gender: All

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. axitinib alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Axitinib

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.