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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359450
• Other study ID #: CA165-026
• Secondary ID: EUDRACT: 2005-00
• Status: Terminated
• Phase: Phase 2
• First received: August 1, 2006
• Last updated: February 27, 2010
• Start date: July 2006

Study information

• Verified date: September 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 186
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• BMS-275183 (oral taxane)

Locations

Country	Name	City	State
Belgium	Local Institution	Charleroi
Belgium	Local Institution	Leuven
Canada	Local Institution	Montreal	Ontario
Canada	Local Institution	St. Jerome	Quebec
Canada	Local Institution	Thunder Bay	Ontario
Canada	Local Institution	Toronto	Ontario
France	Local Institution	Belfort
France	Local Institution	Besancon
France	Local Institution	Poitiers
France	Local Institution	Saint-Herblain Cedex
France	Local Institution	Strasbourg
France	Local Institution	Tours
Italy	Local Institution	Napoli
Italy	Local Institution	Orbassano Torino
Italy	Local Institution	Perugia
Italy	Local Institution	Roma
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Maastricht
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
United Kingdom	Local Institution	Cambridge	Cambridgeshire
United Kingdom	Local Institution	Glasgow	Central
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Northwood	Middlesex
United Kingdom	Local Institution	Oxford	Oxfordshire
United Kingdom	Local Institution	Plymouth	Devon
United States	Local Institution	Burlington	Massachusetts
United States	Local Institution	Cleveland	Ohio
United States	Local Institution	Morganton	North Carolina
United States	Local Institution	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
Secondary	To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population
Secondary	Assess the response duration
Secondary	Assess the progression free survival time
Secondary	Assess the overall survival time
Secondary	Assess the pharmacokinetics (PK) of BMS-275183

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm