NCT01277406已完成1 期
A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Resminostat (4SC-201) in Combination With a Second-line Treatment in Patients With K-ras Mutated Advanced Colorectal Carcinoma
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
- 4SC AG
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Phase I: MTD of 4SC-201 (Resminostat) in combination with FOLFIRI by investigating safety, tolerability and pharmacokinetics
研究概览
简要总结
The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of 4SC-201 (Resminostat) in combination with FOLFIRI and whether 4SC-201 (Resminostat) is effective and safe in combination FOLFIRI versus FOLFIRI alone in the treatment of advanced colorectal carcinoma.
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
- 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
FOLFIRI
Active Comparator
干预措施: FOLFIRI (Drug)
4SC-201+FOLFIRI
Experimental
干预措施: 4SC-201(Resminostat) (Drug)
4SC-201+FOLFIRI
Experimental
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Phase I: MTD of 4SC-201 (Resminostat) in combination with FOLFIRI by investigating safety, tolerability and pharmacokinetics
Phase II: Progression free survival (PFS)
次要结局
- Phase I: Progression free survival (PFS)
- Phase I: Progression free survival rate (PFSR) after 8 weeks (4 cycles) and every following 8 weeks (additional 4 cycles each)
- Phase I: Time to Progression (TTP)
- Phase I: Number of Objective Response (OR)
- Phase I: Overall survival (OS)
- Phase I: Duration of Response (DOR)
- Phase II: Progression free survival rate (PFSR) after 8 weeks (4 cycles) and ever following 8 week (additional 4 cycles each)
- Phase II: Time to Progression (TTP)
- Phase II: Number of Objective Responses (OR)
- Phase II: Duration of Response (DOR)
- Phase II: Safety and tolerability data comprising vital signs, physical examinations, ECGs, clinical laboratory and adverse events
- Phase II: Overall survival (OS)
- Phase II: Pharmacokinetics: AUClast, AUCtau, cmax, tmax, t ½, CL/F of resminostat, Irinotecan (SN-38), 5-FU and folinic acid
研究者
研究点 (3)
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