A Study of ARRY-142886 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
- 57
- 试验地点
- 3
- 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-142886.
This study has 2 parts. In the first part, patients 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 25 patients from the US will be enrolled in Part 1 (Completed).
In the second part of the study, patients 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 the study drug causes and what effectiveness the study drug has, if any, in treating the cancer. Approximately 35 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-142886
干预措施: ARRY-142886, MEK 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
Establish the maximum tolerated dose (MTD) of study drug.
时间窗: Part 1
Assess the biological activity of the study drug in tumors in terms of inhibition of extracellular signal-regulated kinase (ERK) phosphorylation.
时间窗: Part 2
次要结局
- Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.(Part 1 and Part 2)
- Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.(Part 1 and Part 2)
- Assess the efficacy of the study drug in terms of tumor dimension assessment.(Part 1 and Part 2)
- Confirm the safety of the study drug at the MTD as determined by adverse events, clinical laboratory tests, vital signs and electrocardiograms.(Part 2)