Study of XL999 in Patients With Non-small Cell Lung Cancer
Phase 2
Terminated
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT00277329
- Lead Sponsor
- Symphony Evolution, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate Inclusion until disease progression Safety and tolerability Inclusion until 30 dyas post last treatment
- Secondary Outcome Measures
Name Time Method Progression-free survival Inclusion until disease progression Duration of response Inclusion until disease progression Overall survival Inclusion until 180-Day Follow-up post last treatment or death Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters Various time points during the 8-week Study Treatment Period in the second stage of the study
Trial Locations
- Locations (4)
Center for Oncology Research and Treatment, PA
🇺🇸Dallas, Texas, United States
Hematology/Oncology Associates of the Treasure Coast
🇺🇸Port St. Lucie, Florida, United States
Joliet Oncology-Hematology Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Hematology-Oncology Associates of Rockland
🇺🇸Nyack, New York, United States