NCT03838926招募中1 期
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 12
- 主要终点
- Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
研究概览
简要总结
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory 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
- •Subject is ≥ 18 years at the time of signing informed consent;
- •Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies;
- •Presence of measurable or evaluable disease;
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- •Contraceptives or other approved avoidance of pregnancy measures
排除标准
- •Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression;
- •Concomitantly taking anti-cancer therapy (bisphosphonates are permitted);
- •Undergone major surgery ≤ 2 weeks prior to starting study drug;
- •Evidence of mucosal or internal bleeding;
- •Impaired cardiac function or conduction defect;
- •Concurrent severe and/or uncontrolled medical conditions
研究组 & 干预措施
Trichostatin A
Experimental
干预措施: Trichostatin A (Drug)
结局指标
主要结局
Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
时间窗: Up to 24 months
Measured by spontaneous reporting of adverse events (AEs)
Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
时间窗: Up to 24 months
次要结局
未报告次要终点
研究者
研究点 (12)
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