Study of XL999 in Patients With Metastatic Colorectal Cancer

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer (CRC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

Inclusion Criteria:

• Males and females with histologically confirmed metastatic colorectal cancer
• Measurable disease according to Response Criteria for Solid Tumors (RECIST)
• At least 1 prior therapeutic regimen (chemotherapy or biologic)
• 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
• Treatment with systemic anticancer therapy within 30 days of XL999 treatment
• Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other 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