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NCT02949895 Clinical Trial

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

Small Cell Lung Cancer Clinical Trial

Official title:
A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02949895
Other study ID # CA001-045
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 29, 2016
Est. completion date August 29, 2017

Study information
Verified date August 2019
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date August 29, 2017
Est. primary completion date August 29, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• BMS-986012

• Cisplatin

• Etoposide

Locations
Country Name City State
Japan Local Institution Chuo-ku Tokyo
Japan Local Institution Takatsuki-shi Osaka

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events (AEs) Up to 2 years
Primary Number of participants with serious adverse events (SAEs ) Up to 2 years
Primary Number of Discontinuations due to AEs Up to 2 years
Primary Number of Deaths due to AEs Up to 2 years
Primary Number of participants with laboratory toxicity grade shift from baseline Up to 2 years
Secondary Maximum observed serum concentration (Cmax) Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Secondary Time of maximum observed serum concentration(Tmax) Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Best overall response (BOR) Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
Secondary Duration of response (DOR) Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years
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