CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Tepotinib 300 mg +4 moredrug
Likely dose
Tepotinib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01988493
NCT01988493Phase 2Completed
CompareCT.gov

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

Merck KGaA, Darmstadt, Germany·interventional·Posted Nov 20, 2013·Updated Aug 24, 2022

In Brief

A Phase 2 clinical trial evaluating Tepotinib 300 mg, Tepotinib 500 mg, and 3 other interventions for Carcinoma, Hepatocellular. Completed, enrolled 117 participants across 43 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesChina, South Korea, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 20, 2013
Enrollment StartJan 6, 2014
Primary CompletionFeb 5, 2018
Study CompletionDec 3, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.6 years ago

Interventions

Tepotinib 300 mgdrug

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

Tepotinib 500 mgdrug

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

Tepotinib 1000 mgdrug

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

Tepotinibdrug

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.

Sorafenibdrug

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