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

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

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Cisplatin; Drug: Etoposide; Drug: BMS-986012

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Takatsuki-shi, Osaka, Japan, 5698686
      • Local Institution
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1040045
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Dose 1; BMS-986012 Dose Escalation Dose 1	Drug: BMS-986012
Experimental: Dose Escalation Dose 2; BMS-986012 Dose Escalation Dose 2	Drug: BMS-986012
Experimental: Chemotherapy Combination; BMS-986012 + Cisplatin + Etoposide	Drug: Cisplatin; Drug: Etoposide; Drug: BMS-986012

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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
Best overall response (BOR)	Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
Duration of response (DOR)	Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

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