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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00359450

Enrollment

186

Registered

2006-08-02

Start date

2006-07-31

Completion date

Unknown

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Locally advanced or metastatic non-small cell lung cancer

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.

Interventions

DRUGBMS-275183 (oral taxane)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Belgium, Canada, France, Italy, Netherlands, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026