- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00359450
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Charleroi, Belgium
- Local Institution
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Leuven, Belgium
- Local Institution
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Ontario
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Montreal, Ontario, Canada
- Local Institution
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Thunder Bay, Ontario, Canada
- Local Institution
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Toronto, Ontario, Canada
- Local Institution
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Quebec
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St. Jerome, Quebec, Canada
- Local Institution
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Belfort, France
- Local Institution
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Besancon, France
- Local Institution
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Poitiers, France
- Local Institution
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Saint-Herblain Cedex, France
- Local Institution
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Strasbourg, France
- Local Institution
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Tours, France
- Local Institution
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Napoli, Italy
- Local Institution
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Orbassano Torino, Italy
- Local Institution
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Perugia, Italy
- Local Institution
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Roma, Italy
- Local Institution
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Amsterdam, Netherlands
- Local Institution
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Maastricht, Netherlands
- Local Institution
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Barcelona, Spain
- Local Institution
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Madrid, Spain
- Local Institution
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom
- Local Institution
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Central
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Glasgow, Central, United Kingdom
- Local Institution
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Devon
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Plymouth, Devon, United Kingdom
- Local Institution
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Greater London
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London, Greater London, United Kingdom
- Local Institution
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Middlesex
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Northwood, Middlesex, United Kingdom
- Local Institution
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom
- Local Institution
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Massachusetts
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Burlington, Massachusetts, United States
- Local Institution
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Missouri
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St. Louis, Missouri, United States
- Local Institution
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North Carolina
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Morganton, North Carolina, United States
- Local Institution
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Ohio
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Cleveland, Ohio, United States
- Local Institution
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
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Secondary Outcome Measures
Outcome Measure |
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To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population
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Assess the response duration
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Assess the progression free survival time
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Assess the overall survival time
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Assess the pharmacokinetics (PK) of BMS-275183
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA165-026
- EUDRACT: 2005-005099-33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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