NCT03774056已完成1 期
A Phase I Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients With Metastatic Castration-Resistant Prostate 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
- 43
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities(DLT)
研究概览
简要总结
This is a phase I study evaluating tolerability, pharmacokinetics, and preliminary efficacy of HC-1119 in patients with metastatic castration-resistant prostate cancer. The study objective is to study the tolerability, safety, and dose-limiting toxicities (DLT) of HC-1119 in patients with mCRPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 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
dose group
Experimental
Drug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg
干预措施: HC-1119 (Drug)
结局指标
主要结局
Dose-limiting toxicities(DLT)
时间窗: From the first dose of the study to the 12th week after dose
Safety measures
Number of patients with adverse events
时间窗: From the first dose of the study to the 12th week after dose
Safety measures
次要结局
- Maximum drug concentration(Cmax)(From the first dose of the study to the 12th week after dose)
- Time of maximum drug concentration(Tmax)(From the first dose of the study to the 12th week after dose)
- Area under curve from time 0 to 24h (AUC0-24h)(From the first dose of the study to the 12th week after dose)
- Maximal PSA Response Rate(From the first dose of the study to the 12th week after dose)
- Response rate of prostate specific antigen (PSA)(From the first dose of the study to the 12th week after dose)
研究者
研究点 (1)
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