NCT02400788已完成1 期
A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy
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
- 179
- 主要终点
- Phase 2 : Time To Progression (TTP)
研究概览
简要总结
The purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with advanced or metastatic hepatocellular carcinoma
- •Patients with ECOG PS of 0-1
- •Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications
排除标准
- •Patients with a history of treatment with HDAC inhibitors
- •Pregnant women and lactating mothers
- •Patients with brain metastases or suspected brain metastases based on the clinical symptoms
研究组 & 干预措施
Resminostat + Sorafenib
Experimental
oral administration
干预措施: Resminostat (Drug)
Resminostat + Sorafenib
Experimental
oral administration
干预措施: Sorafenib (Drug)
Sorafenib
Active Comparator
oral administration
干预措施: Sorafenib (Drug)
结局指标
主要结局
Phase 2 : Time To Progression (TTP)
时间窗: 12 months
Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability
时间窗: 6 months
次要结局
未报告次要终点
研究者
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