NCT01294735已完成1 期
A Phase I Study of MK-4827 in Combination With Temozolomide in Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Number of participants with DLTs
研究概览
简要总结
This is a non-randomized two-part study of MK-4827 given with temozolomide in participants with advanced cancer. In Part A of the study, the dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of MK-4827 when combined with temozolomide will be found by increasing the MK-4827 dose level in successive cohorts. In Part B of the study, participants with advanced glioblastoma multiforme and advanced melanoma will be enrolled to further evaluate the tolerability and efficacy of the MK-4827 + temozolomide combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
Part A, MK-4827 + temozolomide dose escalation cohort
Experimental
干预措施: MK-4827 (Drug)
Part A, MK-4827 + temozolomide dose escalation cohort
Experimental
干预措施: Temozolomide (Drug)
Part B, MK-4827 + temozolomide melanoma cohort
Experimental
干预措施: MK-4827 (Drug)
Part B, MK-4827 + temozolomide melanoma cohort
Experimental
干预措施: Temozolomide (Drug)
Part B, MK-4827 + temozolomide glioblastoma multiforme cohort
Experimental
干预措施: MK-4827 (Drug)
Part B, MK-4827 + temozolomide glioblastoma multiforme cohort
Experimental
干预措施: Temozolomide (Drug)
结局指标
主要结局
Number of participants with DLTs
时间窗: Cycle 1 (28 days)
次要结局
- Number of participants with an objective response rate of partial or complete response(Baseline, Day 25 of each cycle, within 30 days of last dose, and at 2 month intervals until disease progression or new therapy initiated.)
- Number of participants with 6-month progression-free survival(6 months from baseline imaging)
- Progression-Free Survival (PFS)(First dose to progressive disease or death, whichever occurs first)
研究者
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