A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.
研究概览
简要总结
This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Completed).
In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).
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
ARRY-614
干预措施: ARRY-614, p38/Tie2 inhibitor; oral (Drug)
结局指标
主要结局
Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.
时间窗: Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
时间窗: Part 1, one year
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.
时间窗: Part 1, one year; Part 2, one year
次要结局
- Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.(Part 1, one year; Part 2, one year)