Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

Symphony Evolution

Status and phase

Terminated

Phase 2

Conditions

Renal Cell Carcinoma

Treatments

Drug: XL999

Study type

Interventional

Funder types

Industry

Identifiers

NCT00277316

XL999-201

Details and patient eligibility

About

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 clear cell renal cell carcinoma (RCC). 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

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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