NCT02514603已完成1 期
A Phase 1 Study of LY2606368 in Japanese Patients With Advanced Solid Tumors
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
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)
研究概览
简要总结
The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed
- •Participant must have diagnosis of cancer that is advanced or metastatic
- •Participant must have discontinued previous treatments for cancer and recovered from the acute effects of that therapy
- •If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug
- •If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding
排除标准
- •Participant must not have symptomatic central nervous system malignancy or metastasis
- •Participant must not have current hematologic malignancy
- •Participant must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
- •Participant must not have a serious cardiac condition
研究组 & 干预措施
Prexasertib
Experimental
Prexasertib intravenously (IV) on day 1 of a 14 day cycle. Treatment with prexasertib may continue until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
干预措施: Prexasertib (Drug)
结局指标
主要结局
Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)
时间窗: Cycle 1 (14 day cycle)
次要结局
- Percentage of Participants with a Tumor Response(Baseline to Study Completion (Approximately 24 weeks))
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib(Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days))
- Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib(Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days))
研究者
研究点 (1)
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未知
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A Phase 1 Study of LY2606368 in Japanese Patients with Advanced Solid TumorseoplasmJPRN-jRCT2080222962Eli Lilly Japan K.K.