An Open Label, Phase I Trial of Intravenous Once Every 2 Weeks Administration of BI 6727 (Volasertib) in Japanese Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
研究概览
简要总结
To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese patients with AML
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 99 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
Volasertib
Patient to receive escalating dose of volasertib
干预措施: Volasertib (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
时间窗: From first administration of trial drug up to 28 days
Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the number of participants with DLTs in cycle 1 is presented.
MTD of Volasertib
时间窗: From first administration of trial drug up to 28 days
Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the MTD is presented.
次要结局
- Best Response by Complete Remission (CR)(From first administration of trial drug up to 486 days)
- Best Response by CRi(From first administration of trial drug up to 486 days)
- Best Response by PR(From first administration of trial drug up to 486 days)
- Remission Duration(From first administration of trial drug up to 486 days)