Trials / Completed
CompletedNCT00738530
A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 649 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bevacizumab [Avastin] | 10 mg/kg IV every 2 weeks |
| DRUG | Interferon alfa 2a [Roferon] | 9 MIU SC 3 times/week |
| DRUG | Placebo | IV every 2 weeks |
Timeline
- Start date
- 2004-06-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2008-08-20
- Last updated
- 2016-06-23
- Results posted
- 2016-06-23
Locations
104 sites across 18 countries: Australia, Belgium, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT00738530. Inclusion in this directory is not an endorsement.