Tepotinib in Solid Tumors Harboring MET Alterations

Sponsor
Chungbuk National University Hospital
Study ID
NCT04647838
Phase
PHASE2
Status
Unknown

Conditions

  • MET Amplification
  • MET Exon 14 Skipping Mutation
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • Tepotinib — DRUG
    Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily

Study Details

The aim of this study is to understand efficacy of tepotinib in patients with solid cancers harbouring c-MET amplification or exon 14 mutation who progressed after standard treatment for metastatic disease.

Key Dates

Start date
Jan 16, 2020
Status verified
Nov 2020
Primary completion
Feb 28, 2023
Completion
Aug 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NSCLC
    Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily
  • Experimental: Other cancers
    Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily

Primary Outcome Measure

Objective response rates (RECIST1.1) [ Time Frame: Baseline up to 20 months ]

Central Contacts

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