MedTrace Logo

c-Met Second-Line Hepatocellular Carcinoma

NCT02115373 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-08-24

Study results available
· View outcomes & findings →

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.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Tepotinib

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.

DRUG

Tepotinib

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-18
Primary Completion
2018-02-14
Completion
2018-02-14

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02115373 on ClinicalTrials.gov