Study Comparing Bevacizumab + Temsirolimus Vs Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects (INTORACT)
Tracking Information
Start Date ICMJE | March 2008 |
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Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 28, 2008) | Tumor measurements and survival status [ Time Frame: On going ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00631371 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 28, 2008) | Safety, investigator Assessed PFS, objective response rate, survival [ Time Frame: On going ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study Comparing Bevacizumab + Temsirolimus Vs Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects |
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Official Title ICMJE | Phase 3b, Randomized, Open-Label Study of Bevacizumab + Temsirolimus ) vs. Bevacizumab + Interferon-Alfa as First-Line Treatment in Subjects With Advanced Renal Cell Carcinoma |
Brief 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups | 1: Experimental Experiment (Bevacizumab + Torisel) Interventions:
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Recruitment Information
Estimated Enrollment ICMJE | 800 | ||||
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Estimated Completion Date | February 2012 | ||||
Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00631371 | ||||
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Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||
Study ID Numbers ICMJE | 3066K1-3311 | ||||
Study Sponsor ICMJE | Wyeth | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Wyeth |
Source: http://clinicaltrials.gov/