A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.

A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

Inclusion Criteria:

• Cytokine refractory metastatic renal cell carcinoma with clear cell component
• Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
• Prior nephrectomy

Exclusion Criteria:

• Prior treatment with any systemic therapy other than 1 cytokine therapy
• History of or known brain metastases
• Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start