NCT00491738

A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)

A Multicenter, Phase II, Randomized, Blinded, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Sutent With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic RCC who have not received prior systemic therapy for metastatic disease. The study will enroll approximately 100 patients at approximately 20 centers in the United States.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	bevacizumab	Intravenous repeating dose
DRUG	sunitinib	Oral repeating dose
DRUG	placebo	Intravenous repeating dose

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-01-01
• First posted: 2007-06-26
• Last updated: 2009-04-10
• Results posted: 2009-04-10