A Phase I Study of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Adverse events of oral LCL161
研究概览
简要总结
This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LCL161
Dose escalation part: Eligible patients will start to receive oral LCL161 once a week and will receive weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour, in combination with LCL161 from cycle 2. Dose expansion part: Eligible patients will receive oral LCL161 at the maximum tolerated dose and/or recommended dose in combination with weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour from cycle 1.
干预措施: LCL161 (Drug)
LCL161
Dose escalation part: Eligible patients will start to receive oral LCL161 once a week and will receive weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour, in combination with LCL161 from cycle 2. Dose expansion part: Eligible patients will receive oral LCL161 at the maximum tolerated dose and/or recommended dose in combination with weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour from cycle 1.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Adverse events of oral LCL161
时间窗: From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)
Type and frequency of adverse events of oral LCL161 when administered in combination with weekly paclitaxel
Frequency of dose limiting toxicities as a function of LCL161 during first cycle
时间窗: First cycle (21 days)
次要结局
- LCL161 plasma concentration and derived pharmacokinetic parameters(From first cycle and up to 3 cycle (each cycle is 21-day period))
- Paclitaxel plasma concentration and derived pharmacokinetic parameters(From first cycle of combination and up to 2 cycle (each cycle is 21-day period))
- Adverse events of oral LCL161(From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation))
- Tumor response according to RECIST 1.1(Every 2 cycles for first 8 cycles, then every 3 cycles and until end of treatment (each cycle is 21-day period and end of treatment visit occurs within 7 days after the determination of study discontinuation))