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Clinical Trials/NCT00359450
NCT00359450TerminatedPhase 2

A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients

Bristol-Myers Squibb30 sites in 8 countries186 target enrollmentStarted: July 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
Enrollment
186
Locations
30
Primary Endpoint
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry

Study Sites (30)

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