Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer
Verified date | February 2010 |
Source | Symphony Evolution, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | July 2008 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for Oncology Research and Treatment, PA | Dallas | Texas |
United States | Joliet Oncology-Hematology Associates, Ltd. | Joliet | Illinois |
United States | Hematology-Oncology Associates of Rockland | Nyack | New York |
United States | Hematology/Oncology Associates of the Treasure Coast | Port St. Lucie | Florida |
Lead Sponsor | Collaborator |
---|---|
Symphony Evolution, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Inclusion until disease progression | No | |
Primary | Safety and tolerability | Inclusion until 30 dyas post last treatment | Yes | |
Secondary | Progression-free survival | Inclusion until disease progression | No | |
Secondary | Duration of response | Inclusion until disease progression | No | |
Secondary | Overall survival | Inclusion until 180-Day Follow-up post last treatment or death | No | |
Secondary | Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters | Various time points during the 8-week Study Treatment Period in the second stage of the study | Yes |
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