We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00491738
Recruitment Status : Terminated (Based on the data collected, the combination of bevacizumab and sunitinib appeared to be poorly tolerated.)
First Posted : June 26, 2007
Results First Posted : April 10, 2009
Last Update Posted : April 10, 2009
Information provided by:
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: bevacizumab Drug: sunitinib Drug: placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : January 2008

Arm Intervention/treatment
Experimental: 1 Drug: bevacizumab
Intravenous repeating dose

Drug: sunitinib
Oral repeating dose

Placebo Comparator: 2 Drug: sunitinib
Oral repeating dose

Drug: placebo
Intravenous repeating dose

Primary Outcome Measures :
  1. All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) [ Time Frame: 5 months ]
    Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed Informed Consent Form
  • Histologically confirmed metastatic RCC
  • Measurable disease, as defined by RECIST
  • Age ≥ 18 years
  • ECOG performance status of 0 or 1
  • Prior nephrectomy
  • Ability and capacity to comply with study and follow-up procedures

Exclusion Criteria:

  • RCC with predominantly sarcomatoid features
  • Prior systemic or adjuvant therapy for RCC
  • Radiotherapy for RCC within 28 days prior to Day 1
  • Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or other similar agents
  • Current need for dialysis
  • Life expectancy of < 12 weeks
  • Current, recent, or planned participation in an experimental drug study
  • Inadequate organ function
  • Active infection or fever > 38.5°C within 3 days of starting treatment
  • History of other malignancies within 5 years prior to Day 1
  • Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results
  • Inadequately controlled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Class II or greater CHF
  • History of myocardial infarction or unstable angina within 6 months prior to Day 1
  • History of stroke or transient ischemic attack within 6 months prior to Day 1
  • Known CNS disease except for treated brain metastasis
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1
  • History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Major surgical procedure or anticipation of need for major surgical procedure during the course of the study
  • Serious, non-healing wound; active ulcer; or untreated bone fracture
  • Known hypersensitivity to any component of bevacizumab
  • Pregnancy (positive pregnancy test) or lactation
  • Current, ongoing treatment with full-dose warfarin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491738

Sponsors and Collaborators
Genentech, Inc.
Layout table for investigator information
Study Director: Frank Scappaticci, M.D., Ph.D. Genentech, Inc.
Layout table for additonal information
Responsible Party: Frank A. Scappaticci, M.D., Ph.D., Study Director, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00491738    
Other Study ID Numbers: AVF4167g
First Posted: June 26, 2007    Key Record Dates
Results First Posted: April 10, 2009
Last Update Posted: April 10, 2009
Last Verified: April 2009
Keywords provided by Genentech, Inc.:
Renal cell cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action