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Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma (INTORACT)
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.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 791 |
| Start date | 2008-04 |
| Completion | 2015-04 |
Conditions
- Renal Cell Carcinoma
Interventions
- Bevacizumab
- Temsirolimus
- Bevacizumab
- Interferon-Alfa 9MU
Primary outcomes
- Progression-Free Survival (PFS): Independent-Assessment — Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Countries
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, France, Germany, Hong Kong, Hungary, India, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom