NCT02405065已完成1 期
Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573 in Solid Tumors
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年1月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.
详细描述
Besides the main objective, there are 3 other objectives as follows:
- To evaluate the anti-cancer effect of HM95573 in solid tumor patients
- To investigate the pharmacokinetic profile of HM95573 after oral administration.
- To investigate biomarkers related to the safety and efficacy of HM95573.
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
- •Patients must be 20 years of age or older
- •Subjects who have provided voluntary consent to participate in the study, and signed the written consent document.
- •Estimated life expectancy of at least 12 weeks
- •Histologically or cytologically confirmed advanced solid tumor
排除标准
- •Symptomatic or uncontrolled central nervous system metastases
- •Patients who are unable to take tablets orally or have a clinically significant gastrointestinal disorder, which may interfere with administration, metabolism and absorption of the investigational drug.
- •Patients who, in the investigator's opinion, are not suitable for the study for any other reason.
研究组 & 干预措施
HM95573
Experimental
single arm
干预措施: HM95573 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1
次要结局
- Overall rsponse rate(6-12 weeks)
研究者
研究点 (1)
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