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 | Terminated Phase 2 Results

• 1 other identifier: AVF4167g
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Cell Carcinoma

Keywords

RCC; Renal cell cancer; Avastin; Sutent

Outcome Measures

Primary Outcomes (1)

• All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)

  Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.

  5 months

Study Arms (2)

1

EXPERIMENTAL

Drug: bevacizumab; Drug: sunitinib

2

PLACEBO COMPARATOR

Drug: sunitinib; Drug: placebo

Interventions

bevacizumab DRUG

Intravenous repeating dose

1

sunitinib DRUG

Oral repeating dose

1; 2

placebo DRUG

Intravenous repeating dose

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Bevacizumab; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; 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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Based on the early safety results from this study, Genentech terminated further recruitment and discontinued treatment. Insufficient efficacy information was available to perform additional outcome analyses.

Results Point of Contact

• Title: Medical Communications Specialist
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Frank Scappaticci, M.D., Ph.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2008
• Last Updated: April 10, 2009
• Results First Posted: April 10, 2009

Record last verified: 2009-04