Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer

A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen

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.
• Eastern Cooperative Oncology Group (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 (sunitinib) 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 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 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.