Non-Small Cell Lung CancerPhase 2NCT00651508
Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing KOS-1584 in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy. 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?
- KOS-1584
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2008
- 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
- Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV.
- Eligible patients must have received only one prior chemotherapy regime for Stage IIIB/IV NSCLC.
- Good performance status.
Who cannot join
- Prior treatment with an epothilone.
- Known central nervous system (CNS) metastases.
- Any chemotherapy, radiation therapy or immunotherapy or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to first study drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Consultants In Blood Disorders & Cancer
Louisville, Kentucky, 40207
About this study
Official title: Open Label, Multi-center, Phase 2 Study of KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) Previously Treated With First-Line Chemotherapy
The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- KOS-1584
- Keywords
- Patients with Advanced or Metastatic stage IIIB/IV 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.
KOS-1584Drug
Also called BMS-878271
25 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm 25mg/m2 | Experimental | KOS-1584 25mg/m2 Receives: Drug: KOS-1584 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate of KOS-1584
Measured: up to one year
Secondary outcomes (1)
Progression Free Survival (PFS), Time to Progression (TTP), Time to Treatment Failure (TTF), time to response, duration of response, overall survival and safety of KOS-1584.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionOct 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651508
- Sponsor's protocol ID
- CA202-002
- Other IDs
- KOS-1584-203
- Status last verified
- Apr 2016
- First submitted
- 26 Mar 2008
- Last updated
- 17 May 2016
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-center, Phase 2 Study of KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) Previously Treated With First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT00651508
- Acronym / sponsor ID
- CA202-002
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Patients with Advanced or Metastatic stage IIIB/IV Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Apr 2008 (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.
The purpose of this study is to determine the Objective Response Rate of KOS-1584, as a single agent in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm 25mg/m2 | Experimental | Drug: KOS-1584KOS-1584 25mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV.
- Eligible patients must have received only one prior chemotherapy regime for Stage IIIB/IV NSCLC.
- Good performance status.
Key exclusion criteria (3 listed)
- Prior treatment with an epothilone.
- Known central nervous system (CNS) metastases.
- Any chemotherapy, radiation therapy or immunotherapy or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to first study drug administration.
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 |
|---|---|---|
| KOS-1584Also: BMS-87827125 mg/m2, IV (in the vein) on day 1 and 8 of each 21 day cycle until progression or unacceptable toxicity develops. | Drug | Single Arm 25mg/m2 |
Primary outcome
Objective response rate of KOS-1584
Time frame: up to one year
1 secondary outcome
Progression Free Survival (PFS), Time to Progression (TTP), Time to Treatment Failure (TTF), time to response, duration of response, overall survival and safety of KOS-1584.
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KOS-1584 in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate of KOS-1584 (time frame: up to one year). 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 17 May 2016.