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

Inclusion criteria

• Subjects must have a histologically confirmed metastatic RCC with a clear cell component
• 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

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)