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

Phase 2

Terminated

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT00359450
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-02
• Primary Completion: 2007-03
• Status Verified: 2007-09
• Disposition First Submitted: 2010-02-27
• Disposition First Submitted QC: 2010-02-27
• Last Update Submitted: 2010-02-27
• Disposition First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Oxford, Oxfordshire, United Kingdom