Study of XL999 in Patients With Non-small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with non-small cell lung cancer (NSCLC). 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symphony Evolution, Inc.

Criteria

Inclusion Criteria:

• Males and females with histologically confirmed NSCLC

• Prior treatment with a platinum- or taxane containing regimen

• Stage IIIB with malignant effusion, stage IV or recurrent NSCLC that is not amenable to curative therapy (either surgery or radiation therapy)

• Measurable disease according to Response Criteria for Solid Tumors (RECIST)

• 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

• Use of any systemic anticancer therapy within 30 days of XL999 treatment

• More than 2 prior systemic cytotoxic chemotherapy regimens

• More than 1 prior agent targeted against VEGF or EGFR (eg, bevacizumab, erlotinib, or gefitinib)

• Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days before study enrollment

• Uncontrolled and/or intercurrent illness

• History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis

• Pregnant or breastfeeding females

• Known HIV