NCT02949895已完成1 期
A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2016年11月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Deaths due to AEs
研究概览
简要总结
A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Chemotherapy Combination
Experimental
BMS-986012 + Cisplatin + Etoposide
干预措施: BMS-986012 (Drug)
Dose Escalation Dose 1
Experimental
BMS-986012 Dose Escalation Dose 1
干预措施: BMS-986012 (Drug)
Dose Escalation Dose 2
Experimental
BMS-986012 Dose Escalation Dose 2
干预措施: BMS-986012 (Drug)
Chemotherapy Combination
Experimental
BMS-986012 + Cisplatin + Etoposide
干预措施: Cisplatin (Drug)
Chemotherapy Combination
Experimental
BMS-986012 + Cisplatin + Etoposide
干预措施: Etoposide (Drug)
结局指标
主要结局
Number of Deaths due to AEs
时间窗: Up to 2 years
Number of Discontinuations due to AEs
时间窗: Up to 2 years
Number of participants with adverse events (AEs)
时间窗: Up to 2 years
Number of participants with serious adverse events (SAEs )
时间窗: Up to 2 years
Number of participants with laboratory toxicity grade shift from baseline
时间窗: Up to 2 years
次要结局
- Duration of response (DOR)(Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years)
- 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)
- Best overall response (BOR)(Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years)
- 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)
- 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)
- 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 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)
研究者
研究点 (1)
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