A Study of ARRY-334543 in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
研究概览
简要总结
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada 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-334543
干预措施: ARRY-334543, EGFR/ErbB2 inhibitor; oral (Drug)
结局指标
主要结局
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
时间窗: Part 1 and Part 2
Establish the maximum tolerated dose (MTD) of study drug.
时间窗: Part 1
次要结局
- Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.(Part 1 and Part 2)
- Assess the efficacy of the study drug in terms of tumor dimension assessment.(Part 1 and Part 2)