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

This study has been terminated.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00359450

First received: August 1, 2006

Last updated: February 27, 2010

Last verified: September 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	August 1, 2006
Last Updated Date	February 27, 2010
Start Date ^ICMJE	July 2006
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 7, 2006)	To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
Original Primary Outcome Measures ^ICMJE (submitted: August 1, 2006)	To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate.
Change History	Complete list of historical versions of study NCT00359450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 7, 2006)	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
Original Secondary Outcome Measures ^ICMJE (submitted: August 1, 2006)	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
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
Official Title ^ICMJE	A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non-small Cell Lung Cancer
Intervention ^ICMJE	Drug: BMS-275183 (oral taxane)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	186
Completion Date	Not Provided
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belgium, Canada, France, Italy, Netherlands, Spain, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00359450
Other Study ID Numbers ^ICMJE	CA165-026, EUDRACT: 2005-005099-33
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bristol-Myers Squibb
Verification Date	September 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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