Inclusion Criteria:

• 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.
• ECOG performance status 0 or 1.
• Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1.
• Adequate organ function

Exclusion Criteria:

• Prior treatment with any systemic therapy other than 1 cytokine-based therapy.
• Previous treatment on a SU011248 clinical trial.
• Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
• 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 CT or 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 medical therapy).
• 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.