An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 5
- 主要终点
- Number of participants with dose-limiting toxicities (DLT)
研究概览
简要总结
This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).
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
- •Histologically or cytologically confirmed advanced, recurrent small-cell lung cancer (SCLC) with documented disease progression after at least two (2) prior systemic regimens, including at least one (1) platinum-based regimen.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate hematologic, hepatic and renal function.
排除标准
- •No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.
研究组 & 干预措施
Part A: Rovalpituzumab tesirine
Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle
干预措施: Rovalpituzumab tesirine (Drug)
Part B: Rovalpituzumab tesirine
Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD).
干预措施: Rovalpituzumab tesirine (Drug)
结局指标
主要结局
Number of participants with dose-limiting toxicities (DLT)
时间窗: Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
次要结局
- Duration of response (DOR)(First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.)
- Objective Response Rate (ORR)(First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.)
- Overall survival (OS)(First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.)
- Progression-free survival (PFS)(First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.)
- Clinical benefit rate (CBR)(First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.)