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

February 27, 2010 updated by: Bristol-Myers Squibb

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

Terminated

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

Drug: BMS-275183 (oral taxane)

Study Type

Interventional

Enrollment

186

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Charleroi, Belgium
    - Local Institution
  - Leuven, Belgium
    - Local Institution
Canada
- Ontario
  - Montreal, Ontario, Canada
    - Local Institution
  - Thunder Bay, Ontario, Canada
    - Local Institution
  - Toronto, Ontario, Canada
    - Local Institution
- Quebec
  - St. Jerome, Quebec, Canada
    - Local Institution
France
- - Belfort, France
    - Local Institution
  - Besancon, France
    - Local Institution
  - Poitiers, France
    - Local Institution
  - Saint-Herblain Cedex, France
    - Local Institution
  - Strasbourg, France
    - Local Institution
  - Tours, France
    - Local Institution
Italy
- - Napoli, Italy
    - Local Institution
  - Orbassano Torino, Italy
    - Local Institution
  - Perugia, Italy
    - Local Institution
  - Roma, Italy
    - Local Institution
Netherlands
- - Amsterdam, Netherlands
    - Local Institution
  - Maastricht, Netherlands
    - Local Institution
Spain
- - Barcelona, Spain
    - Local Institution
  - Madrid, Spain
    - Local Institution
United Kingdom
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom
    - Local Institution
- Central
  - Glasgow, Central, United Kingdom
    - Local Institution
- Devon
  - Plymouth, Devon, United Kingdom
    - Local Institution
- Greater London
  - London, Greater London, United Kingdom
    - Local Institution
- Middlesex
  - Northwood, Middlesex, United Kingdom
    - Local Institution
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom
    - Local Institution
United States
- Massachusetts
  - Burlington, Massachusetts, United States
    - Local Institution
- Missouri
  - St. Louis, Missouri, United States
    - Local Institution
- North Carolina
  - Morganton, North Carolina, United States
    - Local Institution
- Ohio
  - Cleveland, Ohio, United States
    - Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

August 1, 2006

First Submitted That Met QC Criteria

August 1, 2006

First Posted (Estimate)

August 2, 2006

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Locally advanced or metastatic non-small cell lung cancer

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.