search
Back to results

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

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-275183 (oral taxane)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Locally advanced or metastatic non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

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

Full Information

First Posted
August 1, 2006
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00359450
Brief Title
Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Locally advanced or metastatic non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
186 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BMS-275183 (oral taxane)
Primary Outcome Measure Information:
Title
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
Secondary Outcome Measure Information:
Title
To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population
Title
Assess the response duration
Title
Assess the progression free survival time
Title
Assess the overall survival time
Title
Assess the pharmacokinetics (PK) of BMS-275183

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Local Institution
City
Burlington
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Local Institution
City
Morganton
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Charleroi
Country
Belgium
Facility Name
Local Institution
City
Leuven
Country
Belgium
Facility Name
Local Institution
City
Montreal
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
St. Jerome
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Belfort
Country
France
Facility Name
Local Institution
City
Besancon
Country
France
Facility Name
Local Institution
City
Poitiers
Country
France
Facility Name
Local Institution
City
Saint-Herblain Cedex
Country
France
Facility Name
Local Institution
City
Strasbourg
Country
France
Facility Name
Local Institution
City
Tours
Country
France
Facility Name
Local Institution
City
Napoli
Country
Italy
Facility Name
Local Institution
City
Orbassano Torino
Country
Italy
Facility Name
Local Institution
City
Perugia
Country
Italy
Facility Name
Local Institution
City
Roma
Country
Italy
Facility Name
Local Institution
City
Amsterdam
Country
Netherlands
Facility Name
Local Institution
City
Maastricht
Country
Netherlands
Facility Name
Local Institution
City
Barcelona
Country
Spain
Facility Name
Local Institution
City
Madrid
Country
Spain
Facility Name
Local Institution
City
Cambridge
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Central
Country
United Kingdom
Facility Name
Local Institution
City
Plymouth
State/Province
Devon
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
Country
United Kingdom
Facility Name
Local Institution
City
Northwood
State/Province
Middlesex
Country
United Kingdom
Facility Name
Local Institution
City
Oxford
State/Province
Oxfordshire
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs