drugset / Trial / 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)

NCT00491738 ↗

Phase 2 Terminated 16 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-08
Primary completion
2008-01
Completion
—

Outcome

Outcome not reported

Stopped: “Based on the data collected, the combination of bevacizumab and sunitinib appeared to be poorly tolerated.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — Intravenous
Background Sunitinib Small molecule — Oral

Indications