AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib

Exclusion Criteria

• •Disease Related
• •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 randomization.
• •Medications
• •Currently or previously treated with inhibitors of VEGF.
• •Currently or previously treated with inhibitors of angiopoietin or Tie2.
• •Currently or previously treated with bevacizumab.
• •General Medical
• •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 surgery
• •Uncontrolled hypertension as defined as diastolic \> 90 mmHg OR systolic \>150 mmHg. Anti-hypertensive medications are permitted.
• •Other
• •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 investigational agent(s)