Spots Global Cancer Trial Database for Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma
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Trial Identification
Brief Title: Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma
Official Title: A Multicenter, Randomized, Phase Ib/II Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of MSC2156119J as Monotherapy Versus Sorafenib in Asian Subjects With MET+ Advanced Hepatocellular Carcinoma and Child-Pugh Class A Liver Function
Study ID: NCT01988493
Conditions
Study Description
Brief Summary: This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line treatment versus sorafenib in subjects with MET+, Barcelona Clinic Liver Cancer (BCLC) Stage C, systemic treatment naive advanced hepatocellular carcinoma (HCC) and Child-Pugh class A liver function.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
307 Hosptial of PLA, Beijing, Beijing, China
Peking University Cancer Hospital, Beijing, Beijing, China
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA, Fuzhou, Fujian, China
Sun Yat-sen University, Cancer Center, Guangzhou, Guangdong, China
Nanfang Hospital, Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Nanjing Bayi Hospital, Nanjing, Jiangsu, China
Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, China
Jilin Cancer Hospital, Changchun, Jilin, China
Shanghai Cancer Hospital, Fudan University, Shanghai, Shanghai, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
Cancer Hospital, Tianjin Medical University, Tianjin, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Zhejiang, Zhejiang, China
Beijing Friendship Hospital, Capital Medical University, Beijing, , China
Dong-A University Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
CHA Bundang Medical Center, CHA University, Seongnam-si,, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Kyung Hee University Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon-si, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan, , Korea, Republic of
Changhua Christian Hospital, Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi Mei Medical Center, Liou Ying, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou, Taoyuan, , Taiwan
Contact Details
Name: Medical Responsible
Affiliation: Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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