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Study of BMS-275183 in Patients With Pre-treated 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
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

Eligibility Criteria

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

Inclusion Criteria: Advanced or metastatic pretreated NSCLC Measurable disease Adequate hematologic, hepatic and renal functions ECOG Performance Status of 0-2 Exclusion Criteria: Inability to swallow capsules Recent significant cardiovascular disease Woman who are pregnant or breastfeeding

Sites / Locations

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Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 21, 2004
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00099879
Brief Title
Study of BMS-275183 in Patients With Pre-treated Non-small Cell Lung Cancer
Official Title
A Randomized, Two-Cohort Phase II Study of Two Doses of BMS-275183 Given on a Weekly Schedule in Patients With Pre-Treated Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this treatment will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BMS-275183

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced or metastatic pretreated NSCLC Measurable disease Adequate hematologic, hepatic and renal functions ECOG Performance Status of 0-2 Exclusion Criteria: Inability to swallow capsules Recent significant cardiovascular disease Woman who are pregnant or breastfeeding
Facility Information:
Facility Name
Local Institution
City
Sacramento
State/Province
California
Country
United States
Facility Name
Local Institution
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Maywood
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Local Institution
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Brussels
Country
Belgium
Facility Name
Local Institution
City
Leuven
Country
Belgium
Facility Name
Local Institution
City
Besancon
State/Province
Cedex
Country
France
Facility Name
Local Institution
City
Saint-Herblain
State/Province
Cedex
Country
France
Facility Name
Local Institution
City
Belfort
Country
France
Facility Name
Local Institution
City
Parma
Country
Italy
Facility Name
Local Institution
City
Roma
Country
Italy
Facility Name
Local Institution
City
Amsterdam
Country
Netherlands
Facility Name
Local Insitution
City
Groningen
Country
Netherlands
Facility Name
Local Institution
City
Barcelona
Country
Spain
Facility Name
Local Institution
City
Madrid
Country
Spain
Facility Name
Local Institution
City
Shefield
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

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Study of BMS-275183 in Patients With Pre-treated Non-small Cell Lung Cancer

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