A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK ofMSC2156119J as Monotherapy in Subjects with MET+ Advanced Hepatocellular Carcinoma withChild Pugh Class A Liver Function Who Have Failed Sorafenib Treatment - c-Met Second-line HCC

Merck KGaA0 个研究点目标入组 66 人开始时间: 2014年2月3日最近更新: 2018年6月11日

适应症

试验速览

暂无简介。

•1. Histologically or cytologically confirmed HCC;
•2. Child Pugh Class A liver function score;
•3. For phase II only: MET+ status
•4. Male or female, 18 years of age or older;
•5. Measurable disease in accordance with RECIST Version 1.1;
•6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
•(inclusive);
•7. Previously treated with sorafenib for = 4 weeks and discontinued sorafenib treatment
•at least 14 days prior to Day 1 due to either intolerance or radiographic progression;
•8. Signed and dated informed consent indicating that the subject (or legally acceptable
•representative if applicable by local laws) has been informed of all the pertinent
•aspects of the trial prior to enrollment;
•9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
•tests and other trial procedures; and
•10. Life expectancy of at least 3 months as judged by the investigator.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 33
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 33

•1. Prior systemic anticancer treatment for advanced HCC (except for sorafenib as
•described in the inclusion criteria);
•2. Prior treatment with any agent targeting the HGF/c-Met pathway;
•3. Local-regional therapy within 4 weeks before Day 1
•4. Impaired cardiac function
•5. Additional exclusion criteria could apply.

发起方