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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: BMS-275183 (oral taxane)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359450

EUDRACT: 2005-005099-33

CA165-026

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)