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

This study has been terminated.
(Based on the data collected, the combination of bevacizumab and sunitinib appeared to be poorly tolerated.)
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00491738
First received: June 25, 2007
Last updated: April 9, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Renal Cell Carcinoma
Drug: bevacizumab
Drug: sunitinib
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491738

Sponsors and Collaborators
Genentech
Investigators
Study Director: Frank Scappaticci, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Frank A. Scappaticci, M.D., Ph.D., Study Director, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00491738     History of Changes
Other Study ID Numbers: AVF4167g
Study First Received: June 25, 2007
Results First Received: February 6, 2009
Last Updated: April 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
RCC
Renal cell cancer
Avastin
Sutent

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014