NCT00359450

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
8 countries

30 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

March 2, 2010

Status Verified

September 1, 2007

Enrollment Period

8 months

First QC Date

August 1, 2006

Last Update Submit

February 27, 2010

Conditions

Non-small Cell Lung Cancer

Keywords

Locally advanced or metastatic non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

BMS-275183 (oral taxane)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, age \>= 18 years
  • Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen.

You may not qualify if:

  • Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Local Institution

Burlington, Massachusetts, United States

Location

Local Institution

St Louis, Missouri, United States

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Local Institution

Morganton, North Carolina, United States

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Cleveland, Ohio, United States

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Charleroi, Belgium

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Leuven, Belgium

Location

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Montreal, Ontario, Canada

Location

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Saint-Jérôme, Quebec, Canada

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Belfort, France

Location

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Besançon, France

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Poitiers, France

Location

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Saint-Herblain, France

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Strasbourg, France

Location

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Tours, France

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Napoli, Italy

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Orbassano Torino, Italy

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Perugia, Italy

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Roma, Italy

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Amsterdam, Netherlands

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Maastricht, Netherlands

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Barcelona, Spain

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Madrid, Spain

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Cambridge, Cambridgeshire, United Kingdom

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Glasgow, Central, United Kingdom

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Plymouth, Devon, United Kingdom

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London, Greater London, United Kingdom

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Northwood, Middlesex, United Kingdom

Location

Local Institution

Oxford, Oxfordshire, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

BMS-275183taxane

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 2, 2006

Study Start

July 1, 2006

Primary Completion

March 1, 2007

Last Updated

March 2, 2010

Record last verified: 2007-09

Locations

NL(2)IT(4)GB(6)BE(2)CA(4)FR(6)ES(2)US(4)