Clinical trial NCT00359450: Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Locally advanced or metastatic non-small cell lung cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
Secondary outcomes:
measure: To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population
measure: Assess the response duration
measure: Assess the progression free survival time
measure: Assess the overall survival time
measure: Assess the pharmacokinetics (PK) of BMS-275183
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Local Institution
state: Massachusetts
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Morganton
country: United States
facility: Local Institution
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Charleroi
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Montreal
country: Canada
facility: Local Institution
state: Ontario
city: Thunder Bay
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: St. Jerome
country: Canada
facility: Local Institution
state: Quebec
city: Belfort
country: France
facility: Local Institution
city: Besancon
country: France
facility: Local Institution
city: Poitiers
country: France
facility: Local Institution
city: Saint-Herblain Cedex
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Tours
country: France
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Orbassano Torino
country: Italy
facility: Local Institution
city: Perugia
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Maastricht
country: Netherlands
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Cambridge
country: United Kingdom
facility: Local Institution
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Central
city: Plymouth
country: United Kingdom
facility: Local Institution
state: Devon
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Northwood
country: United Kingdom
facility: Local Institution
state: Middlesex
city: Oxford
country: United Kingdom
facility: Local Institution
state: Oxfordshire
Study officials:
References: