A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0337 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose by assessing dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase 1, open label, multi-center study of orally administered DSP-0337 in adult subjects with advance solid tumors that are refractory to standard treatment, or for whom no effective therapy exists.
详细描述
The study is comprised of two parts: an initial dose escalation phase utilizing a 3 + 3 design to determine maximum tolerated dose followed by a dose expansion cohort in approximately 30 additional subjects. Study participants will initially receive DSP-0337 orally for 28 days (one cycle of treatment). If clinical benefit is seen, treatment can continue until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
DSP-0337
In Part 1 - Up to six dose levels will be investigated in dose-escalating cohorts to identify a maximum tolerated dose (MTD). An additional subset of patients will be treated to assess the effect of food intake on the PK of DSP-0337 administration at the MTD level. Once the recommended Phase 2 dose (RP2D) has been established, patients will be treated with the RP2D to explore preliminary antitumor activity and safety profile.
干预措施: DSP-0337 (Drug)
结局指标
主要结局
Maximum tolerated dose by assessing dose-limiting toxicities (DLTs)
时间窗: 4 weeks
Dose escalating cohort
Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)
时间窗: 4 weeks
Dose escalating cohort
次要结局
- Pharmacokinetics by assessing drug concentration in blood(4 weeks)
- Urine excretion of napabucasin after DSP-0337 administration(24 hours)
- Objective response rate (ORR)(6 months)
- Number of Patients with Adverse Events(12 months)
- Time to progression (TTP)(6 months)
- Progression free survival (PFS)(12 months)