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Study of BMS-986012 in Subjects With Small Cell Lung Caner

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BMS-986012
Cisplatin
Etoposide
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Escalation Dose 1

Dose Escalation Dose 2

Chemotherapy Combination

Arm Description

BMS-986012 Dose Escalation Dose 1

BMS-986012 Dose Escalation Dose 2

BMS-986012 + Cisplatin + Etoposide

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs )
Number of Discontinuations due to AEs
Number of Deaths due to AEs
Number of participants with laboratory toxicity grade shift from baseline

Secondary Outcome Measures

Maximum observed serum concentration (Cmax)
Time of maximum observed serum concentration(Tmax)
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
Observed serum concentration at the end of a dosing interval(Ctau)
Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA)
Best overall response (BOR)
Duration of response (DOR)

Full Information

First Posted
October 28, 2016
Last Updated
August 8, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02949895
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
August 29, 2017 (Actual)
Study Completion Date
August 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Dose 1
Arm Type
Experimental
Arm Description
BMS-986012 Dose Escalation Dose 1
Arm Title
Dose Escalation Dose 2
Arm Type
Experimental
Arm Description
BMS-986012 Dose Escalation Dose 2
Arm Title
Chemotherapy Combination
Arm Type
Experimental
Arm Description
BMS-986012 + Cisplatin + Etoposide
Intervention Type
Drug
Intervention Name(s)
BMS-986012
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Etoposide
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 2 years
Title
Number of participants with serious adverse events (SAEs )
Time Frame
Up to 2 years
Title
Number of Discontinuations due to AEs
Time Frame
Up to 2 years
Title
Number of Deaths due to AEs
Time Frame
Up to 2 years
Title
Number of participants with laboratory toxicity grade shift from baseline
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Maximum observed serum concentration (Cmax)
Time Frame
Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Title
Time of maximum observed serum concentration(Tmax)
Time Frame
Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Title
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))
Time Frame
Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Title
Observed serum concentration at the end of a dosing interval(Ctau)
Time Frame
Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Title
Area under the concentration-time curve in 1 dosing interval(AUC(TAU))
Time Frame
Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Title
Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA)
Time Frame
Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Title
Best overall response (BOR)
Time Frame
Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
Title
Duration of response (DOR)
Time Frame
Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

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Study of BMS-986012 in Subjects With Small Cell Lung Caner

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