Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bevacizumab; Everolimus; Interferon-alpha; Interferons; Sirolimus

Criteria

Inclusion Criteria:

• Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)

• Majority component of conventional clear-cell type is mandatory

• At least 1 measurable lesion (per RECIST)

Exclusion Criteria:

• Prior systemic treatment for RCC

• Evidence of current or prior central nervous system (CNS) metastases

• Cardiovascular disease

• Pregnant or nursing women

• Additional criteria applies