NCT00943449已完成2 期
A Proof-of-concept Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of 4SC-201 and the Treatment Combination of Sorafenib Plus 4SC-201 in Patients With Hepatocellular Carcinoma Exhibiting Progressive Disease Under Sorafenib Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 4SC AG
- 入组人数
- 57
- 试验地点
- 15
- 主要终点
- Progression Free Survival Rate (PFSR) of repeated oral doses of 4SC-201 and of the treatment combination of Sorafenib plus 4SC-201
研究概览
简要总结
The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Advanced stage hepatocellular carcinoma
- •Patients exhibiting progressive disease under Sorafenib treatment
- •Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included
- •ECOG performance status 0, 1 or 2
- •Precedent first-line treatment with Sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks
排除标准
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) - any cancer curatively treated > 3 years prior to entry is permitted
- •Renal failure requiring hemo- or peritoneal dialysis
- •Known central nervous system (CNS) tumors including symptomatic brain metastasis
- •Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I
- •Pregnant or breastfeeding women
- •Sorafenib intolerance
- •Major surgery within the last 4 weeks
研究组 & 干预措施
4SC-201
Experimental
干预措施: 4SC-201 (Drug)
4SC-201 + Sorafenib
Experimental
干预措施: 4SC-201 (Drug)
4SC-201 + Sorafenib
Experimental
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression Free Survival Rate (PFSR) of repeated oral doses of 4SC-201 and of the treatment combination of Sorafenib plus 4SC-201
时间窗: 12 weeks
次要结局
- To establish the MTD of 4SC-201 in combination with Sorafenib(12 weeks)
- To investigate the safety and tolerability of repeated oral doses of 4SC-201 and of the treatment combination of ascending repeated oral doses of 4SC-201 and Sorafenib(12 weeks)
- To investigate biomarkers(12 weeks)
研究者
研究点 (15)
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