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
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)