A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination With AMG 386 or Placebo In Subjects With Metastatic Clear Cell Carcinoma of the Kidney
- Subjects must have a histologically confirmed metastatic RCC with a clear cell
- Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center
(MSKCC) prognostic risk classification.
- Measurable disease with at least one unidimensionally measurable lesion per RECIST
guidelines with modifications
- Adequate organ and hematological function as evidenced by laboratory studies
conducted at Screening.
- ECOG of 0 or 1
- Known history of central nervous system metastases.
- Previous treatment (excluding surgery and palliative radiotherapy) for advanced or
metastatic renal cell carcinoma
- Focal radiation therapy for palliation of pain from bony metastases within 14 days of
- Currently or previously treated with inhibitors of VEGF.
- Currently or previously treated with inhibitors of angiopoietin or Tie2.
- Currently or previously treated with bevacizumab.
- Diagnosis of acute pancreatitis.
- Myocardial infarction, cerebrovascular accident, transient ischemic attack,
percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade
2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient
medication, or unstable angina within 1 year prior to randomization
- Major surgery within 30 days before randomization or still recovering from prior
- Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg.
Anti-hypertensive medications are permitted.
- Other investigational procedures are excluded
- Subject currently is enrolled in or has not yet completed at least 30 days since
ending other investigational device or drug study(s), or subject is receiving other