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

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