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

NCT00631371 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 791

Last updated 2016-04-27

Study results available
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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.

Conditions

Interventions

DRUG

Bevacizumab

Bevacizumab 10 mg/kg intravenous (IV) q8wks

DRUG

Temsirolimus

Temsirolimus 25 mg IV weekly

DRUG

Bevacizumab

Bevacizumab 10 mg/kg intravenous (IV) q8wks

DRUG

Interferon-Alfa 9MU

Interferon-Alfa 9MU SC TIW

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-04-30
Completion
2015-04-30

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00631371 on ClinicalTrials.gov