- Histologically documented RCC with metastases.
- Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to
disease progression or unacceptable treatment-related toxicity
- Any prior systemic treatment for Renal Cell Carcinoma [RCC] other than 1 prior
cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an
anti-angiogenesis agent are not allowed.
- Inability to take oral medication