Non Small Cell Lung CancerPhase 1NCT00461110
A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
A Phase 1 study testing BMS-663513 in people with Non Small Cell Lung Cancer, run by Bristol-Myers Squibb at 4 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin. 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-663513
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2008to Apr 2009
- Phase
- Phase 1
- 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
- NSCLC who are eligible to receive a 6 week course of RT
- Part 1 - not candidates for definitive RT
- Part 2 - candidates for definitive RT
Who cannot join
- Severe COPD, pulmonary infection or interstitial pneumonitis
- Recent cellulitis
- Autoimmune disease
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University Of Texas Southwestern Medical Center
Dallas, Texas, 75390
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, 08901
Nyu Clinical Cancer Center
New York, New York, 10016
Thomas Jefferson Univ Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- BMS-663513
- 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-663513Drug
Also called Anti-CD137
mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active Receives: Drug: BMS-663513 |
| 2 | Experimental | Active Receives: Drug: BMS-663513 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma
Measured: throughout the study
Secondary outcomes (4)
Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers
Measured: end of study
Describe anti-tumor activity
Measured: throughout the study
Obtain blood and plasma for exploratory research
Measured: several timepoints throughout the study
Obtain archival tissue for predictive marker research
Measured: at screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startJan 2008
- Primary completionApr 2009
- Study completionApr 2009 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461110
- Sponsor's protocol ID
- CA186-005
- Status last verified
- Sep 2009
- First submitted
- 13 Apr 2007
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)
- ClinicalTrials.gov ID
- NCT00461110
- Acronym / sponsor ID
- CA186-005
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (estimated)
- First posted
- 17 Apr 2007 (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 maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BMS-663513Active |
| 2 | Experimental | Drug: BMS-663513Active |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NSCLC who are eligible to receive a 6 week course of RT
- Part 1 - not candidates for definitive RT
- Part 2 - candidates for definitive RT
Key exclusion criteria (3 listed)
- Severe COPD, pulmonary infection or interstitial pneumonitis
- Recent cellulitis
- Autoimmune disease
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-663513Also: Anti-CD137mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks | Drug | 1, 2 |
Primary outcome
To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma
Time frame: throughout the study
4 secondary outcomes
Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers
Time frame: end of study
Describe anti-tumor activity
Time frame: throughout the study
Obtain blood and plasma for exploratory research
Time frame: several timepoints throughout the study
Obtain archival tissue for predictive marker research
Time frame: at screening
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 4 Sep 2009.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-663513 in people with Non Small Cell Lung Cancer, run by Bristol-Myers Squibb at 4 sites 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: stopped early, as of the sponsor's last update on 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma (time frame: throughout the study). 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 4 Sep 2009.