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

Sponsor
Genentech, Inc.
Study ID
NCT00491738
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    Intravenous repeating dose
  • sunitinib — DRUG
    Oral repeating dose
  • placebo — DRUG
    Intravenous repeating dose

Study Details

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.

Key Dates

First listed
Jun 26, 2007
Start date
Aug 31, 2007
Status verified
Apr 2009
Primary completion
Jan 31, 2008

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) [ Time Frame: 5 months ]

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