A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Intervention: bevacizumab; sunitinib; placebo
Intervention description: Intravenous repeating dose; Oral repeating dose; Intravenous repeating dose
Intervention MeSH terms: Bevacizumab; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RCC; Renal cell cancer; Avastin; Sutent

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.
    

Eligibility 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