jRCT2080223369未知1 期
A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
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
次要结局
- Following PK Parameters
研究者
相似试验
已完成
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