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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

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