CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Tepotinib +1 moredrug
Likely dose
Tepotinib 300 milligramfrom 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/NCT02115373
NCT02115373Phase 2Completed
CompareCT.gov

A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK of MSC2156119J as Monotherapy in Subjects With MET+ Advanced Hepatocellular Carcinoma With Child Pugh Class A Liver Function Who Have Failed Sorafenib Treatment

Merck KGaA, Darmstadt, Germany·interventional·Posted Apr 16, 2014·Updated Aug 24, 2022

In Brief

A Phase 2 clinical trial evaluating Tepotinib for Carcinoma, Hepatocellular. Completed, enrolled 66 participants across 1 site.

Detailed Summary

This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced hepatocellular carcinoma (HCC) with child Pugh Class A liver function who have failed sorafenib treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 16, 2014
Enrollment StartMay 18, 2014
Primary CompletionFeb 14, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 12.2 years ago

Interventions

Tepotinibdrug

Participants received a single oral dose of Tepotinib 300 milligram (mg) in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.

Tepotinibdrug

Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.