drugset / Trial / NCT00796757

A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

NCT00796757

Phase 2 Completed 146 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Timeline

Start
2008-12
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject interferon alfa Protein / enzyme biologic 3 iu Subcutaneous

Indications