Overview

This trial is active, not recruiting.

Condition renal cell carcinoma
Treatments bevacizumab, temsirolimus, interferon-alfa 9mu
Phase phase 3
Targets mTOR, VEGF
Sponsor Pfizer
Start date April 2008
End date April 2012
Trial size 791 participants
Trial identifier NCT00631371, 3066K1-3311, B1771006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
bevacizumab Torisel
Bevacizumab 10 mg/kg intravenous (IV) q8wks
temsirolimus
Temsirolimus 25 mg IV weekly
(Active Comparator)
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks
interferon-alfa 9mu
Interferon-Alfa 9MU SC TIW

Primary Outcomes

Measure
Progression-Free Survival (PFS): Independent-Assessment
time frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Secondary Outcomes

Measure
Progression-Free Survival (PFS): Investigator-Assessment
time frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment
time frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Overall Survival (OS)
time frame: Baseline until death due to any caused, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Pfizer.