BMS-275183 given orally twice weekly to patients pretreated for locally advanced or metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the patients enrolled: * Cohort I: Patients previously treated with one taxane containing regimen. * Cohort II: Patients previously treated with a platinum based but non-taxane containing regimen. * Cohort III: Patients previously treated with both a chemotherapy regimen and one EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound. Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound. Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR inhibitor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
Local Institution
Burlington, Massachusetts, United States
Local Institution
St Louis, Missouri, United States
Local Institution
Morganton, North Carolina, United States
Local Institution
Cleveland, Ohio, United States
Local Institution
Charleroi, Belgium
Local Institution
Leuven, Belgium
Local Institution
Montreal, Ontario, Canada
Local Institution
Thunder Bay, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Saint-Jérôme, Quebec, Canada
...and 20 more locations
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population
Assess the response duration
Assess the progression free survival time
Assess the overall survival time
Assess the pharmacokinetics (PK) of BMS-275183
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