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

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

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.

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