A Study of ARRY-380 in Patients With Advanced HER2+ Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Characterize the safety profile of the study drug 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 advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380.
This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Completed).
In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, will receive the best dose of study drug 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 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).
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-380
干预措施: ARRY-380, HER2 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 and electrocardiograms.
时间窗: Part 1, one year; Part 2, one year
Characterize the pharmacokinetics of the study drug.
时间窗: Part 2, one year
Assess amplification/expression of HER2 in archival and tumor tissues.
时间窗: Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
时间窗: Part 1, one year
次要结局
- Assess expression of growth factor pathway proteins in archival and tumor tissues.(Part 2, one year)
- Characterize the pharmacokinetics of the study drug.(Part 1, one year)
- Assess changes in tumor markers.(Part 1, one year)
- Assess the efficacy of study drug in terms of tumor response and duration of response.(Part 1, one year; Part 2, one year)