Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma

Sponsor
Merck KGaA, Darmstadt, Germany
Study ID
NCT01988493
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

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

Interventions

  • Tepotinib 300 mg — DRUG
    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 — DRUG
    Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
  • Tepotinib 1000 mg — DRUG
    Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal
  • Tepotinib — DRUG
    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 — DRUG
    Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.

Study Details

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.

Key Dates

Start date
Jan 6, 2014
Status verified
Aug 2022
Primary completion
Feb 5, 2018
Completion
Dec 3, 2020

Study Design

Enrollment
117 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Phase 1b: Number of Participants Experiencing Dose Limiting Toxicity [ Time Frame: Day 1 to Day 21 of Cycle 1 (each cycle is 21 days) ]

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