Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

Inclusion Criteria:

- Histologically documented metastatic renal cell cancer with a component of clear cell
histology.

- 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.

Exclusion Criteria:

- Prior treatment for metastatic renal cell cancer with more that one systemic first
line therapy.

- Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.