Small Cell Lung CancerPhase 1NCT02949895
Study of BMS-986012 in Subjects With Small Cell Lung Caner
A Phase 1 study testing BMS-986012, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by Bristol-Myers Squibb at 2 sites in Japan.
Trial summary
A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- BMS-986012, Cisplatin and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesJapan
- Study dates
- 29 Nov 2016to 29 Aug 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Histological or cytological confirmed small cell lung cancer (SCLC)
- Eastern Cooperative Oncology Group Performance Status 0-1
- at least one measurable lesion that is not amenable to resection.
- Adequate organ function
Who cannot join
- Symptomatic central nervous system (CNS) metastases
- Grade ≥ 2 peripheral neuropathy
- Uncontrolled or significant cardiac disease
- Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Local Institution
Chuo-ku, Tokyo, 1040045
Local Institution
Takatsuki-shi, Osaka, 5698686
About this study
Official title: A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer
A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer
- Conditions
- Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Dose 1 | Experimental | BMS-986012 Dose Escalation Dose 1 Receives: Drug: BMS-986012 |
| Dose Escalation Dose 2 | Experimental | BMS-986012 Dose Escalation Dose 2 Receives: Drug: BMS-986012 |
| Chemotherapy Combination | Experimental | BMS-986012 + Cisplatin + Etoposide Receives: Drug: BMS-986012; Drug: Cisplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 2 years
Number of participants with serious adverse events (SAEs )
Measured: Up to 2 years
Number of Discontinuations due to AEs
Measured: Up to 2 years
Number of Deaths due to AEs
Measured: Up to 2 years
Number of participants with laboratory toxicity grade shift from baseline
Measured: Up to 2 years
Secondary outcomes (8)
Maximum observed serum concentration (Cmax)
Measured: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Time of maximum observed serum concentration(Tmax)
Measured: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
Measured: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Observed serum concentration at the end of a dosing interval(Ctau)
Measured: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
Measured: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA)
Measured: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Best overall response (BOR)
Measured: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
Duration of response (DOR)
Measured: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start29 Nov 2016
- Primary completion29 Aug 2017
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 7 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
- NCT02949895
- Sponsor's protocol ID
- CA001-045
- Status last verified
- Aug 2019
- First submitted
- 28 Oct 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02949895
- Acronym / sponsor ID
- CA001-045
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 31 Oct 2016 (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.
A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Dose 1 | Experimental | Drug: BMS-986012BMS-986012 Dose Escalation Dose 1 |
| Dose Escalation Dose 2 | Experimental | Drug: BMS-986012BMS-986012 Dose Escalation Dose 2 |
| Chemotherapy Combination | Experimental | Drug: BMS-986012, Drug: Cisplatin, Drug: EtoposideBMS-986012 + Cisplatin + Etoposide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Histological or cytological confirmed small cell lung cancer (SCLC)
- Eastern Cooperative Oncology Group Performance Status 0-1
- at least one measurable lesion that is not amenable to resection.
- Adequate organ function
Key exclusion criteria (5 listed)
- Symptomatic central nervous system (CNS) metastases
- Grade ≥ 2 peripheral neuropathy
- Uncontrolled or significant cardiac disease
- Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
- Other protocol defined inclusion/exclusion criteria could apply
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-986012 | Drug | Chemotherapy Combination, Dose Escalation Dose 1, Dose Escalation Dose 2 |
| Cisplatin | Drug | Chemotherapy Combination |
| Etoposide | Drug | Chemotherapy Combination |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 2 years
Number of participants with serious adverse events (SAEs )
Time frame: Up to 2 years
Number of Discontinuations due to AEs
Time frame: Up to 2 years
Number of Deaths due to AEs
Time frame: Up to 2 years
Number of participants with laboratory toxicity grade shift from baseline
Time frame: Up to 2 years
8 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Time of maximum observed serum concentration(Tmax)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Observed serum concentration at the end of a dosing interval(Ctau)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Best overall response (BOR)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
Duration of response (DOR)
Time frame: Cycle 1(each cycle is 21 days) Day 1 up to approximately 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 12 Aug 2019.
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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
2 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-986012, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by Bristol-Myers Squibb at 2 sites in Japan.
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 5 inclusion and 5 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 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?
Number of participants with adverse events (AEs) (time frame: Up to 2 years). The study lists 5 primary outcomes in all. 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 12 Aug 2019.