NCT00323739

Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma

Phase II Trial of Bevacizumab(Avastin) and RAD001(Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with metastatic renal cell carcinoma. In this trial the investigators will evaluate this combination in patients previously untreated with any anti-angiogenesis agent and patients who have previously received one prior regimen containing an anti-angiogenesis agent.

Detailed description

All eligible patients will receive: * Bevacizumab 10mg/kg, IV infusion, every 2 weeks * RAD001 10 mg by mouth daily All patients will be evaluated for response after completing two courses (8 weeks) of treatment. Patients with objective tumor response or stable disease will continue treatment with bevacizumab adn RAD001 on the same schedule. Treatment will continue until disease progression occurs.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab	Bevacizumab 10mg/kg, IV infusion, every 2 weeks
DRUG	RAD001	RAD001 10 mg by mouth daily

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-11-01
• Completion: 2011-03-01
• First posted: 2006-05-09
• Last updated: 2013-07-26
• Results posted: 2013-03-06

Locations

12 sites across 1 country: United States