Study of XL999 in Patients With Previously Treated Ovarian Cancer

Symphony Evolution

Status and phase

Terminated

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: XL999

Study type

Interventional

Funder types

Industry

Identifiers

NCT00277290

XL999-202

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)