SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma

The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.

Inclusion Criteria:

• Histologically proven renal cell carcinoma of clear cell histology with metastases
• Evidence of measurable disease
• Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
• Prior radical or partial nephrectomy

Exclusion Criteria:

• Prior treatment with any other anti-angiogenic therapy other than bevacizumab
• Prior systemic treatment for RCC > 2 regimens
• History of or known brain metastases
• Serious acute or chronic illness or recent history of significant cardiac abnormality