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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

CA165-026

NCT ID:

NCT00359450

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Locally advanced or metastatic non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Local InstitutionCincinnati, Ohio  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionWilmington, North Carolina  
Local InstitutionColumbia, Missouri