A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Number of Participants With Any Clinical or Laboratory Adverse Event
研究概览
简要总结
This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
MK-1496 20 mg (21-Day Cycle)
Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
干预措施: MK-1496 (Drug)
MK-1496 40 mg (21-Day Cycle)
Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
干预措施: MK-1496 (Drug)
MK-1496 80 mg (21-Day Cycle)
Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
干预措施: MK-1496 (Drug)
MK-1496 120 mg (21-Day Cycle)
Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
干预措施: MK-1496 (Drug)
MK-1496 20 mg (28-Day Cycle)
Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
干预措施: MK-1496 (Drug)
MK-1496 40 mg (28-Day Cycle)
Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
干预措施: MK-1496 (Drug)
MK-1496 80 mg (28-Day Cycle)
Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
干预措施: MK-1496 (Drug)
MK-1496 100 mg (28-Day Cycle)
Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
干预措施: MK-1496 (Drug)
MK-1496 120 mg (28-Day Cycle)
Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
干预措施: MK-1496 (Drug)
结局指标
主要结局
Number of Participants With Any Clinical or Laboratory Adverse Event
时间窗: First dose up to 30 days after last dose (up to 2 years)
This is a measure of the number of participants who experienced any adverse event (AE) while on study.
Number of Participants With Dose-limiting Toxicities (DLTs)
时间窗: Cycle 1 (up to 21 or 28 days, depending on treatment arm)
Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.
次要结局
- Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)(Cycle 1, Day 3 (Hour 0 through Hour 24))
- Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)(Cycle 1, Day 1 (Hour 0 through Hour 24))
- Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)(Cycle 1, Day 1 (Hour 0 through Hour 24))