A Phase Ib Study of BTK Inhibitor DTRMWXHS-12 in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety: Incidence and severity of (serious) adverse events n each patient according to the NCI-CTCAE4.03 grading
研究概览
简要总结
The Primary Objective is to evaluate the safety and tolerability of the DTRMWXHS-12 capsule in patients with relapsed/refractory MCL and recommend the dose and dosing method (RP2D) used in phase II study.
The Secondary Objective is to evaluate the pharmacokinetics (PK) of multiple dose oral administration of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.
The Exploratory Objective is to preliminarily evaluate the efficacy of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.
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 75 Years（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
Experimental Treatment
DTRMWXHS-12, oral capsule, daily, 28 days as a cycle
干预措施: DTRMWXHS-12 (Drug)
结局指标
主要结局
Safety: Incidence and severity of (serious) adverse events n each patient according to the NCI-CTCAE4.03 grading
时间窗: Starting from date of first dose up to 35 days after last dose
To monitor AEs and SAEs in each patient according to the NCI-CTCAE4.03 grading criteria by evaluating changes in physical examination, laboratory tests, and 12-lead ECG during the whole study
次要结局
- concentration of drug in plasma(From date of first dose to day 56)