Non-small Cell Lung CancerPhase 2NCT00359450
Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
A Phase 2 study testing BMS-275183 (oral taxane) in people with Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 30 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- BMS-275183 (oral taxane)
- Type of treatment
- Pill or oral medicine
- How many people
- 186 participants
- Where
- 30 sitesin 8 countries
- Study dates
- Jul 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age >= 18 years
- Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen.
Who cannot join
- Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
France6 sites
Local Institution
Belfort
Local Institution
Besançon
Local Institution
Poitiers
Local Institution
Saint-Herblain
Local Institution
Strasbourg
Local Institution
Tours
United Kingdom6 sites
Local Institution
Cambridge, Cambridgeshire
Local Institution
Glasgow, Central
Local Institution
London, Greater London
Local Institution
Northwood, Middlesex
Local Institution
Oxford, Oxfordshire
Local Institution
Plymouth, Devon
United States4 sites
Local Institution
Burlington, Massachusetts
Local Institution
Cleveland, Ohio
Local Institution
Morganton, North Carolina
Local Institution
St Louis, Missouri
Canada4 sites
Local Institution
Montreal, Ontario
Local Institution
Saint-Jérôme, Quebec
Local Institution
Thunder Bay, Ontario
Local Institution
Toronto, Ontario
Italy4 sites
Local Institution
Naples
Local Institution
Orbassano Torino
Local Institution
Perugia
Local Institution
Roma
Netherlands2 sites
Local Institution
Amsterdam
Local Institution
Maastricht
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- BMS-275183 (oral taxane)
- Keywords
- Locally advanced or metastatic non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-275183 (oral taxane)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359450
- Sponsor's protocol ID
- CA165-026
- Other IDs
- EUDRACT: 2005-005099-33
- Status last verified
- Sep 2007
- First submitted
- 1 Aug 2006
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00359450
- Acronym / sponsor ID
- CA165-026
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Locally advanced or metastatic non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 186 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2007 (actual)
- First posted
- 2 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women, age >= 18 years
- Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen.
Key exclusion criteria (1 listed)
- Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-275183 (oral taxane) | Drug | – |
Primary outcome
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate
5 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-275183 (oral taxane) in people with Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France, United Kingdom, United States, Canada, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.