Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
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|ClinicalTrials.gov Identifier: NCT00359450|
Recruitment Status : Terminated
First Posted : August 2, 2006
Last Update Posted : March 2, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: BMS-275183 (oral taxane)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2006|
|Primary Completion Date :||March 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359450
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