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

Stopped early · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00277329

Run by

Symphony Evolution, Inc.

People needed

9

Starts

2005-12-01

Expected to finish

2008-07-01

Last updated by the study team

2010-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hematology/Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Hematology-Oncology Associates of Rockland — Nyack, New York, United States
• Center for Oncology Research and Treatment, PA — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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