- Histologically documented metastatic renal cell cancer with a component of clear cell
- Evidence of measurable disease.
- Patients with mRCC must have received no prior systemic first-line therapy or must
have progressive disease per RECIST (version 1.0) after one prior systemic first line
regimen for metastatic disease containing sunitinib, cytokine(s), or both.
- Prior treatment for metastatic renal cell cancer with more that one systemic first
- Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.