Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients|
- 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
|Study Start Date:||July 2006|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
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