Clinical trial NCT02949895: Study of BMS-986012 in Subjects With Small Cell Lung Caner
Official title: A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 2 years
measure: Number of participants with serious adverse events (SAEs )
timeFrame: Up to 2 years
measure: Number of Discontinuations due to AEs
timeFrame: Up to 2 years
measure: Number of Deaths due to AEs
timeFrame: Up to 2 years
measure: Number of participants with laboratory toxicity grade shift from baseline
timeFrame: Up to 2 years
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
measure: Time of maximum observed serum concentration(Tmax)
timeFrame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
timeFrame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
measure: Observed serum concentration at the end of a dosing interval(Ctau)
timeFrame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
measure: Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
timeFrame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
measure: Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA)
timeFrame: Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
measure: Best overall response (BOR)
timeFrame: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
measure: Duration of response (DOR)
timeFrame: Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
Other outcomes:
Locations:
city: Takatsuki-shi
country: Japan
facility: Local Institution
state: Osaka
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: