c-Met Second-Line Hepatocellular Carcinoma

Sponsor
Merck KGaA, Darmstadt, Germany
Study ID
NCT02115373
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tepotinib — DRUG
    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.
  • Tepotinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 18, 2014
Status verified
Aug 2022
Primary completion
Feb 14, 2018
Completion
Feb 14, 2018

Study Design

Enrollment
66 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Tepotinib 300 mg
  • Experimental: Phase 1b: Tepotinib 500 mg
  • Experimental: Phase 2: Tepotinib 500 mg

Primary Outcome Measure

Phase 1b: Number of Participants Experiencing Dose Limiting Toxicity (DLT) According to National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) for Adverse Events (AEs) Version 4.0 [ Time Frame: Day 1 to Day 21 of Cycle 1 (each cycle was 21 days) ]

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