Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma
NCT ID: NCT01988493
Last Updated: 2022-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
117 participants
INTERVENTIONAL
2014-01-06
2020-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b: 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.
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.
Phase 1b: Tepotinib 500 mg
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
Tepotinib 500 mg
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
Phase 1b: Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal
Phase 2: 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.
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.
Phase 2 Sorafenib
Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
Sorafenib
Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
Interventions
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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.
Tepotinib 500 mg
Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
Tepotinib 1000 mg
Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal
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.
Sorafenib
Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
Eligibility Criteria
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Inclusion Criteria
* Participants were either intermediate HCC of BCLC Stage B, who were not eligible for surgical and/or local-regional therapies or who had progressive disease (PD) after surgical and/or local-regional therapies (note: the local-regional therapy must not contain sorafenib), or advanced HCC of BCLC Stage C
* Participants who had disease progression on or were intolerant to the prior standard treatment for advanced HCC (phase Ib Korean subjects only)
* A tumor biopsy was required for determining MET status
* MET+ status (Phase 2 only), as determined by the central laboratory (Phase 1b retrospectively, Phase 2 for participant selection) were defined in the protocol
* Child-Pugh class A with no encephalopathy according to the screening assessment
* Asian male or female, 18 years of age or older
* Measurable disease in accordance with RECIST v1.1 (Phase 2 only)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
* Eligible for treatment with sorafenib, was assessed by investigators according to the Package Insert and clinical judgment (Phase 2 only)
* Signed and dated informed consent indicating that the participants had been informed of all the pertinent aspects of the trial prior to enrollment
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures
* Life expectancy was judged by the investigator of at least 3 months
Exclusion Criteria
* Prior treatment with any agent targeting the hepatocyte growth factor (HGF)/c-Met pathway
* Prior local-regional therapy within 4 weeks prior to Day 1 of trial treatment
* Prior history of liver transplant
* Laboratory index at baseline were defined in the protocol
* Past or current history of neoplasm other than HCC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years
* Known central nervous system (CNS) or brain metastasis that is either symptomatic or untreated
* Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested products
* Clinically significant gastrointestinal bleeding within 4 weeks before trial entry
* Peripheral neuropathy Grade greater than or equal to 2 (Common Terminology Criteria for Adverse Events \[CTCAE\] v4.0)
* Impaired cardiac function was defined in the protocol
* Hypertension uncontrolled by standard therapies
* Participants with a family history of long QT syndrome or who take any agent that is known to prolong QT/QTc interval
* Known human immunodeficiency virus (HIV) infection
* Particpants who had acute pancreatitis and/or chronic pancreatitis, with elevated lipase and/or amylase, clinical symptoms, and/or imaging studies that are indicative of the diagnosis (Mainland Chinese participants only)
* Known or suspected drug hypersensitivity to any ingredients of sorafenib (Phase 2 only) and MSC2156119J
* Female participants who were pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug
* Concurrent treatment with a non-permitted drug
* Substance abuse, other acute or chronic medical or psychiatric condition, or laboratory abnormalities that may increase the risk associated with trial participation in the opinion of the investigator
* Participation in another clinical trial within the past 28 days
* Previous anticancer treatment-related toxicities not recovered to baseline or Grade 0-1 (except alopecia and peripheral neuropathy)
* Participants with any concurrent medical condition or disease that will potentially compromise the conduct of the study at the discretion of the investigators
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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307 Hosptial of PLA
Beijing, Beijing Municipality, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, 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, Hu'nan, 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 Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 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, , South Korea
Pusan National University Hospital
Busan, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chi Mei Medical Center, Liou Ying
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Countries
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References
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Ryoo BY, Cheng AL, Ren Z, Kim TY, Pan H, Rau KM, Choi HJ, Park JW, Kim JH, Yen CJ, Lim HY, Zhou D, Straub J, Scheele J, Berghoff K, Qin S. Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression. Br J Cancer. 2021 Jul;125(2):200-208. doi: 10.1038/s41416-021-01380-3. Epub 2021 May 10.
Xiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
Redacted Clinical study report, redacted clinical study protocol and redacted statistical analysis plan for this study is also available at the HC-PRCI portal (Health Canada-Public release of clinical information)
Other Identifiers
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200095-004
Identifier Type: -
Identifier Source: org_study_id
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