drugset / Trial / NCT00631371

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

NCT00631371

Phase 3 Completed 791 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-04
Primary completion
2012-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Temsirolimus Small molecule 25 mg Intravenous
Comparator interferon alfa Protein / enzyme biologic 9 unknown Subcutaneous

Indications