- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02949895
Study of BMS-986012 in Subjects With Small Cell Lung Caner
August 8, 2019 updated by: Bristol-Myers Squibb
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Osaka
-
Takatsuki-shi, Osaka, Japan, 5698686
- Local Institution
-
-
Tokyo
-
Chuo-ku, Tokyo, Japan, 1040045
- Local Institution
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation Dose 1
BMS-986012 Dose Escalation Dose 1
|
|
Experimental: Dose Escalation Dose 2
BMS-986012 Dose Escalation Dose 2
|
|
Experimental: Chemotherapy Combination
BMS-986012 + Cisplatin + Etoposide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events (AEs)
Time Frame: Up to 2 years
|
Up to 2 years
|
Number of participants with serious adverse events (SAEs )
Time Frame: Up to 2 years
|
Up to 2 years
|
Number of Discontinuations due to AEs
Time Frame: Up to 2 years
|
Up to 2 years
|
Number of Deaths due to AEs
Time Frame: Up to 2 years
|
Up to 2 years
|
Number of participants with laboratory toxicity grade shift from baseline
Time Frame: Up to 2 years
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed serum concentration (Cmax)
Time Frame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2016
Primary Completion (Actual)
August 29, 2017
Study Completion (Actual)
August 29, 2017
Study Registration Dates
First Submitted
October 28, 2016
First Submitted That Met QC Criteria
October 28, 2016
First Posted (Estimate)
October 31, 2016
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
August 8, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Etoposide
- Cisplatin
Other Study ID Numbers
- CA001-045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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