Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
This study has been terminated.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00359450
First received: August 1, 2006
Last updated: February 27, 2010
Last verified: September 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: BMS-275183 (oral taxane) |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 186 |
| Study Start Date: | July 2006 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359450
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Hide Study LocationsLocations
| United States, Massachusetts | |
| Local Institution | |
| Burlington, Massachusetts, United States | |
| United States, Missouri | |
| Local Institution | |
| St. Louis, Missouri, United States | |
| United States, North Carolina | |
| Local Institution | |
| Morganton, North Carolina, United States | |
| United States, Ohio | |
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| Cleveland, Ohio, United States | |
| Belgium | |
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| Charleroi, Belgium | |
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| Leuven, Belgium | |
| Canada, Ontario | |
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| Montreal, Ontario, Canada | |
| Local Institution | |
| Thunder Bay, Ontario, Canada | |
| Local Institution | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
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| St. Jerome, Quebec, Canada | |
| France | |
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| Belfort, France | |
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| Besancon, France | |
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| Poitiers, France | |
| Local Institution | |
| Saint-Herblain Cedex, France | |
| Local Institution | |
| Strasbourg, France | |
| Local Institution | |
| Tours, France | |
| Italy | |
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| Napoli, Italy | |
| Local Institution | |
| Orbassano Torino, Italy | |
| Local Institution | |
| Perugia, Italy | |
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| Roma, Italy | |
| Netherlands | |
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| Amsterdam, Netherlands | |
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| Maastricht, Netherlands | |
| Spain | |
| Local Institution | |
| Barcelona, Spain | |
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| Madrid, Spain | |
| United Kingdom | |
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| Cambridge, Cambridgeshire, United Kingdom | |
| Local Institution | |
| Glasgow, Central, United Kingdom | |
| Local Institution | |
| Plymouth, Devon, United Kingdom | |
| Local Institution | |
| London, Greater London, United Kingdom | |
| Local Institution | |
| Northwood, Middlesex, United Kingdom | |
| Local Institution | |
| Oxford, Oxfordshire, United Kingdom | |
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00359450 History of Changes |
| Other Study ID Numbers: | CA165-026, EUDRACT: 2005-005099-33 |
| Study First Received: | August 1, 2006 |
| Last Updated: | February 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Locally advanced or metastatic non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013