Study of BMS-986012 in Subjects With Small Cell Lung Caner
Phase 1
Completed
- Conditions
- Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02949895
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy Combination Cisplatin BMS-986012 + Cisplatin + Etoposide Chemotherapy Combination Etoposide BMS-986012 + Cisplatin + Etoposide Chemotherapy Combination BMS-986012 BMS-986012 + Cisplatin + Etoposide Dose Escalation Dose 1 BMS-986012 BMS-986012 Dose Escalation Dose 1 Dose Escalation Dose 2 BMS-986012 BMS-986012 Dose Escalation Dose 2
- Primary Outcome Measures
Name Time Method Number of participants with laboratory toxicity grade shift from baseline Up to 2 years Number of Deaths due to AEs Up to 2 years Number of Discontinuations due to AEs Up to 2 years Number of participants with adverse events (AEs) Up to 2 years Number of participants with serious adverse events (SAEs ) Up to 2 years
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years 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 Best overall response (BOR) Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years Maximum observed serum concentration (Cmax) 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 Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA) 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 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
Trial Locations
- Locations (1)
Local Institution
🇯🇵Chuo-ku, Tokyo, Japan