Study of XL999 in Patients With Previously Treated Ovarian Cancer

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Recurrent Ovarian Cancer

This clinical trial is being conducted at multiple sites to evaluate the activity, safety, and tolerability of XL999 when given weekly to patients with ovarian cancer that has previously been treated with platinum-based chemotherapy. 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:

• Female patients with a histologically confirmed diagnosis of metastatic ovarian cancer
• Measurable disease according to Response Criteria for Solid Tumors (RECIST)
• Prior treatment with platinum-based therapy
• Platinum-sensitive or platinum-resistant disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of ≥3 months
• Adequate organ and marrow function
• Signed informed consent
• No other malignancies within 5 years

Exclusion Criteria:

• Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
• Use of an investigational drug or cytotoxic chemotherapy within 30 days of XL999 treatment
• Prior anticancer therapy targeting VEGF (eg, bevacizumab, sorafenib, or sunitinib)
• More than two prior systemic non-platinum cytotoxic chemotherapy regimens
• 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
• Patients who are pregnant or breastfeeding
• Known human immunodeficiency virus (HIV)