Clinical trial NCT02815592: Trial of BMS-986012 in Combination With Platinum and Etoposide
Official title: A Phase 1/2 Randomized Trial of BMS-986012 in Combination With Platinum and Etoposide as First-line Therapy in Extensive-Stage 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: 2016-06-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male and Females 18 years of age or older
* Pulmonary SCLC documented by histology or cytology
* Extensive disease (Stage IV) SCLC
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Prior systemic therapy for lung cancer
* Symptomatic brain metastases
* Grade 2 peripheral neuropathy
* Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV
* Other active malignancies or prior malignancy within 2 years

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Cycle 1, Day 1 up to approximately 26 months.
measure: Number of participants with serious adverse events (SAEs )
timeFrame: Date of enrollment up to approximately 26 months.
measure: Discontinuations due to AEs
timeFrame: Cycle 1, Day 1 up to approximately 26 months.
measure: Number of participants who died due to AEs
timeFrame: Cycle 1, Day 1 up to approximately 26 months.
measure: Number of participants with laboratory toxicity grade shift from baseline
timeFrame: Cycle 1, Day 1 up to approximately 26 months.
measure: Progression Free Survival
timeFrame: From date of first dose or randomization until date of confirmed disease progression, up to 2 years
Secondary outcomes:
measure: Maximum observed serum concentration(Cmax)
timeFrame: Cycle 1 Day 1 up to 60 days after last dose
measure: Time of maximum observed serum concentration(Tmax)
timeFrame: Cycle 1 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 Day 1 up to 60 days after last dose
measure: Observed serum concentration at the end of a dosing interval(Ctau)
timeFrame: Cycle 1 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 Day 1 up to 60 days after last dose
measure: Characterization of Immunogenicity
timeFrame: Cycle 1 Day 1 up to 60 days after last dose
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Local Institution - 0002
city: Madrid
country: Spain
facility: Local Institution - 0004
city: Majadahonda - Madrid
country: Spain
facility: Local Institution - 0003
city: Malaga
country: Spain
facility: Local Institution - 0010
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: