At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 649 enrolled
Drug / intervention
Bevacizumab [Avastin] +2 moredrug
Likely dose
Bevacizumab [Avastin] 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.
A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
In Brief
A Phase 3 clinical trial evaluating Bevacizumab [Avastin], Interferon alfa 2a [Roferon], and 1 other intervention for Renal Cell Cancer. Completed, enrolled 649 participants across 104 sites in 18 countries.
Detailed Summary
This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Cancer
CountriesAustralia, Belgium, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
First PostedAug 2008
Primary CompletionSep 2008
TodayJul 2026
First PostedAug 20, 2008
Enrollment StartJun 1, 2004
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.9 years ago
Interventions
Bevacizumab [Avastin]drug
10 mg/kg IV every 2 weeks
Interferon alfa 2a [Roferon]drug
9 MIU SC 3 times/week
Placebodrug
IV every 2 weeks