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

NCT ID: NCT00359450

Last Updated: 2010-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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BMS-275183 (oral taxane)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Burlington, Massachusetts, United States

Site Status

Local Institution

St Louis, Missouri, United States

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Local Institution

Morganton, North Carolina, United States

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Local Institution

Cleveland, Ohio, United States

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Local Institution

Charleroi, , Belgium

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Local Institution

Leuven, , Belgium

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Local Institution

Montreal, Ontario, Canada

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Local Institution

Thunder Bay, Ontario, Canada

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Local Institution

Toronto, Ontario, Canada

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Local Institution

Saint-Jérôme, Quebec, Canada

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Local Institution

Belfort, , France

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Local Institution

Besançon, , France

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Local Institution

Poitiers, , France

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Local Institution

Saint-Herblain, , France

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Local Institution

Strasbourg, , France

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Local Institution

Tours, , France

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Local Institution

Napoli, , Italy

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Local Institution

Orbassano Torino, , Italy

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Local Institution

Perugia, , Italy

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Local Institution

Roma, , Italy

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Local Institution

Amsterdam, , Netherlands

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Local Institution

Maastricht, , Netherlands

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Local Institution

Barcelona, , Spain

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Local Institution

Madrid, , Spain

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Local Institution

Cambridge, Cambridgeshire, United Kingdom

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Local Institution

Glasgow, Central, United Kingdom

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Local Institution

Plymouth, Devon, United Kingdom

Site Status

Local Institution

London, Greater London, United Kingdom

Site Status

Local Institution

Northwood, Middlesex, United Kingdom

Site Status

Local Institution

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United States Belgium Canada France Italy Netherlands Spain United Kingdom

Other Identifiers

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EUDRACT: 2005-005099-33

Identifier Type: -

Identifier Source: secondary_id

CA165-026

Identifier Type: -

Identifier Source: org_study_id

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