Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

Inclusion Criteria:

Males and females with histologically confirmed metastatic clear cell RCC
Measurable disease according to Response Criteria for Solid Tumors (RECIST)
No prior systemic cytotoxic chemotherapy
Subjects who have received either no prior therapy for RCC, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting VEGF or a VEGFR (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled
ECOG performance status of 0 or 1
Life expectancy ≥3 months
Adequate organ and marrow function
No other malignancies within 5 years
Signed informed consent

Exclusion Criteria:

Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
Subjects who have received systemic anticancer therapy within 30 days of XL999 treatment
Subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to medications administered >30 days prior to study enrollment
History of or known brain metastases, current spinal cord compression or carcinomatous meningitis
Uncontrolled and/or intercurrent illness
Pregnant or breastfeeding females
Known HIV