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

February 27, 2010 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

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
      • Brussels, Belgium
        • Local Institution
      • Leuven, Belgium
        • Local Institution
  • France
      • Belfort, France
        • Local Institution
    • Cedex
      • Besancon, Cedex, France
        • Local Institution
      • Saint-Herblain, Cedex, France
        • Local Institution
  • Italy
      • Parma, Italy
        • Local Institution
      • Roma, Italy
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands
        • Local Institution
      • Groningen, Netherlands
        • Local Insitution
  • Spain
      • Barcelona, Spain
        • Local Institution
      • Madrid, Spain
        • Local Institution
  • United Kingdom
      • Manchester, United Kingdom
        • Local Institution
    • Yorkshire
      • Shefield, Yorkshire, United Kingdom
        • Local Institution
  • United States
    • California
      • Sacramento, California, United States
        • Local Institution
    • Connecticut
      • New Haven, Connecticut, United States
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
    • Illinois
      • Maywood, Illinois, United States
        • Local Institution
    • Michigan
      • Detroit, Michigan, United States
        • Local Institution
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, 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

No

Genders Eligible for Study

All

Description

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

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: Randomized

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

December 7, 2022

Primary Completion (Actual)

March 1, 2006

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

December 21, 2004

First Submitted That Met QC Criteria

December 21, 2004

First Posted (Estimate)

December 22, 2004

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA165-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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