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

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00359450
First received: August 1, 2006
Last updated: February 27, 2010
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: BMS-275183 (oral taxane)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

Estimated Enrollment: 186
Study Start Date: July 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359450

  Show 30 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00359450     History of Changes
Other Study ID Numbers: CA165-026, EUDRACT: 2005-005099-33
Study First Received: August 1, 2006
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Locally advanced or metastatic non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014