A Phase III randomized double-blind, placebo-controlled trial of ARQ 197 in subjects with c-MET diagnostic-high inoperable hepatocellular carcinoma (HCC) treated with one prior sorafenib therapy

Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 160 人开始时间: 2013年12月27日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Informed consent form
•2) 20 years or older
•3) Inoperable HCC which is not eligible for locoregional therapy
•4) Diagnosed as c-Met high in tumor sample
•5) Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy.
•6) ECOG PS is 0 or 1
•7) Child-Pugh Class A
•8) Having measurable target lesions which are defined by RECIST version 1.1,
•9) Negative pregnancy test results
•10) Adequate organ function
•11) Life expectancy of at least 12 weeks

•1) More than 2 prior systemic chemotherapy.
•2) Prior therapy of c-Met inhibitor (including antibody)
•3) Any systemic therapy within 2 weeks prior to the randomization
•4) Locoregional therapy within 4 weeks prior to randomization.
•5) Major surgery within 4 weeks prior to the randomization
•6) Concurrent cancer within 5 years prior to the randomization
•7) History of cardiac diseases
•8) Active clinically serious infections defined as Grade 3 or higher according to CTCAE 4.0
•9) Any psychological disorder affecting Informed Consent
•10) Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody
•11) Blood or albumin transfusion within 14 days prior to the screening test
•12) Concurrent interferon therapy against HBV/HCV
•13) Symptomatic brain metastases
•14) History of liver transplantation
•15) Inability to swallow oral medications
•16) Confirmed interstitial lung disease
•18) Pleural effusion and/or clinically significant ascites
•19) Pregnancy or breast-feeding
•20) Without consent to effective single or combined contraceptive methods

发起方

Kyowa Hakko Kirin Co., Ltd.