Study of BMS-986012 in Subjects With Small Cell Lung Caner
A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer
1 other identifier
interventional
7
1 country
2
Brief Summary
A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
November 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2017
CompletedAugust 12, 2019
August 1, 2019
9 months
October 28, 2016
August 8, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
Number of participants with adverse events (AEs)
Up to 2 years
Number of participants with serious adverse events (SAEs )
Up to 2 years
Number of Discontinuations due to AEs
Up to 2 years
Number of Deaths due to AEs
Up to 2 years
Number of participants with laboratory toxicity grade shift from baseline
Up to 2 years
Secondary Outcomes (8)
Maximum observed serum concentration (Cmax)
Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Time of maximum observed serum concentration(Tmax)
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))
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)
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))
Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
- +3 more secondary outcomes
Study Arms (3)
Dose Escalation Dose 1
EXPERIMENTALBMS-986012 Dose Escalation Dose 1
Dose Escalation Dose 2
EXPERIMENTALBMS-986012 Dose Escalation Dose 2
Chemotherapy Combination
EXPERIMENTALBMS-986012 + Cisplatin + Etoposide
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Local Institution
Takatsuki-shi, Osaka, 5698686, Japan
Local Institution
Chuo-ku, Tokyo, 1040045, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
October 31, 2016
Study Start
November 29, 2016
Primary Completion
August 29, 2017
Study Completion
August 29, 2017
Last Updated
August 12, 2019
Record last verified: 2019-08