A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of Dose limiting toxicities
研究概览
简要总结
In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.
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
- •Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit.
- •Availability of a representative formalin fixed paraffin embedded tumor tissue sample.
- •At least one measurable or non-measurable lesion
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- •Good organ (hepatic, kidney, BM) function at screening/baseline visit.
排除标准
- •Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
- •Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
- •Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
MEK162
MEK162 will be administered orally once on Day 1 of Cycle 1 and continuously on a BID schedule, starting on Day 2 of Cycle 1 and on Day 1 of subsequent cycles. Each cycle will be 28 days in duration. Dose will be escalated and starting dose is 30 mg. Any doses that are missed should be skipped and should not be replaced or made up during the evening dosing or on a subsequent day, whichever applies.
The prescribed BID doses should be taken 12 ± 2 hrs apart.
干预措施: MEK162 (Drug)
结局指标
主要结局
Incidence of Dose limiting toxicities
时间窗: 4 weeks
Incidence of frequency of Dose limiting toxicities during first 4 weeks will be measured according to the commen terminology criteria for adverse events (CTCAE).
次要结局
- Tumor responses according to RECIST 1.1(4 months)
- Incidence and severity of adverse events and serious adverse events, changes in laboratory values(4 months)
- Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.(2 months)
- Levels of p-ERK in tumor and skin(4 months)