CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 791 enrolled
Drug / intervention
Bevacizumab +3 moredrug
Likely dose
Bevacizumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00631371
NCT00631371Phase 3Completed

Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma

Pfizer·interventional·Posted Mar 7, 2008·Updated Apr 27, 2016

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Temsirolimus, and 1 other intervention for Renal Cell Carcinoma. Completed, enrolled 791 participants across 172 sites in 30 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2008
Enrollment StartApr 1, 2008
Primary CompletionApr 1, 2012
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.3 years ago

Interventions

Bevacizumabdrug

Bevacizumab 10 mg/kg intravenous (IV) q8wks

Temsirolimusdrug

Temsirolimus 25 mg IV weekly

Bevacizumabdrug

Bevacizumab 10 mg/kg intravenous (IV) q8wks

Interferon-Alfa 9MUdrug

Interferon-Alfa 9MU SC TIW