- Histologically proven renal cell carcinoma with metastases.
- Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in
Solid Tumors (RECIST).
- Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated
with IFN-á alone must have received IFN-á for at least 4 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Resolution of all acute toxic effects of prior therapy or surgical procedures to grade
- Adequate organ function
- Prior treatment with any systemic therapy other than 1 cytokine-based therapy.
- Previous treatment on a SU011248 (sunitinib) clinical trial.
- Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the
- Diagnosis of any second malignancy within the last 3 years, except basal cell
carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately
treated with no evidence of recurrent disease for 12 months.
- History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or new evidence of brain or leptomeningeal disease on screening Computed
Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
- Any of the following within the 12 months prior to starting the study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure, cerebrovascular accident or transient ischemic
attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc
interval >450 msec for males or >470 msec for females.
- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
- Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to
2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- Known human immunodeficiency virus (HIV) infection.