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

Phase 1

• Conditions: Small Cell Lung Cancer

• Registration Number: jRCT2080223369
• Lead Sponsor: Bristol-Myers Squibb K.K.

Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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 Greater than or equal to 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)

Study & Design

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Following PK Parameters		Cmax, Tmax, AUC(0-T), Ctau, AUC(TAU)