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Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00359450
First Posted: August 2, 2006
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
August 1, 2006
August 2, 2006
March 2, 2010
July 2006
March 2007   (Final data collection date for primary outcome measure)
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate.
Complete list of historical versions of study NCT00359450 on ClinicalTrials.gov Archive Site
  • 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 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 PK of BMS-275183
Not Provided
Not Provided
 
Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
Drug: BMS-275183 (oral taxane)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
186
Not Provided
March 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women, age >= 18 years
  • Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen.

Exclusion Criteria:

  • Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
 
 
NCT00359450
CA165-026
EUDRACT: 2005-005099-33
Not Provided
Not Provided
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP