Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

January 6, 2014

Primary Completion Date

February 5, 2018

Study Completion Date

December 3, 2020

Conditions
Carcinoma, Hepatocellular
Interventions
DRUG

Tepotinib 300 mg

Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.

DRUG

Tepotinib 500 mg

Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.

DRUG

Tepotinib 1000 mg

Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal

DRUG

Tepotinib

Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.

DRUG

Sorafenib

Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.

Trial Locations (43)

100

National Taiwan University Hospital, Taipei

333

Chang Gung Memorial Hospital, Linkou, Taoyuan District

704

National Cheng Kung University Hospital, Tainan City

736

Chi Mei Medical Center, Liou Ying, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

10408

National Cancer Center, Goyang-si

10449

Mackay Memorial Hospital, Taipei

11217

Taipei Veterans General Hospital, Taipei

13496

CHA Bundang Medical Center, CHA University, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

40705

Taichung Veterans General Hospital, Taichung

41931

Keimyung University Dongsan Hospital, Daegu

50004

Changhua Christian Hospital, Changhua

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

100071

307 Hosptial of PLA, Beijing

100142

Peking University Cancer Hospital, Beijing

110744

Seoul National University Hospital, Seoul

130012

Jilin Cancer Hospital, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200032

Shanghai Cancer Hospital, Fudan University, Shanghai

Zhongshan Hospital Fudan University, Shanghai

210002

Nanjing Bayi Hospital, Nanjing

210029

Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing

300060

Cancer Hospital, Tianjin Medical University, Tianjin

310016

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Zhejiang

350025

Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA, Fuzhou

410013

The Third Xiangya Hospital of Central South University, Changsha

510060

Sun Yat-sen University, Cancer Center, Guangzhou

510515

Nanfang Hospital, Guangzhou

602-715

Dong-A University Hospital, Busan

602-739

Pusan National University Hospital, Busan

700-721

Kyungpook National University Hospital, Daegu

02447

Kyung Hee University Hospital, Seoul

02841

Korea University Anam Hospital, Seoul

03722

Severance Hospital, Yonsei University, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

443-380

Ajou University Hospital, Suwon

626-770

Pusan National University Yangsan Hospital, Yangsan

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01988493 - Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter