NCT04865458终止1 期
A Phase I Single Arm,Open-label,Multiple Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose
研究概览
简要总结
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies
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
- •Age is over 18 years old
- •Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies
- •ECOG performance status (PS) 0 ~ 1
- •Expected survival of > or = 3 months
排除标准
- •The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group)
- •Received any other anti-cancer treatment within 4 weeks
- •Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption
- •Allergy, or known to have a history of allergy to the drug components
研究组 & 干预措施
HEC89736 treatment
Experimental
HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle
干预措施: HEC89736 (Drug)
结局指标
主要结局
Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose
时间窗: Dosing started until the 28th day
Incidence of dose limited toxicities and associated dose of HEC89736
Adverse events evaluated by NCI CTCAE 5.0
时间窗: From the frst dose to within 30 days after the last dose
Incidence of adverse events and associated dose of HEC89736
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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