Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT04454476
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Gastric Cancer
  • Initial-onset Gastric Cancer
  • Metaplasia
  • Stage I Gastric Cancer

Eligibility Criteria

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

Interventions

  • Trametinib treatment — DRUG
    1 mg taken by mouth once a day for 14 days
  • Endoscopy — PROCEDURE
    A tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies.

Study Details

This is a study of the safety and effectiveness of Trametinib treatment in patients who have received successful endoscopic submucosal resection of a Stage I gastric cancer.

Key Dates

Start date
Nov 9, 2022
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trametinib treatment

Primary Outcome Measure

Effectiveness of Trametinib in reversing metaplasia: changes in cell lineages [ Time Frame: About 12 months ]

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