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.
Objectives: * To evaluate the efficacy of Trametinib in reversing metaplasia in participants with Stage 1 gastric cancer * To evaluate the safety of Trametinibin in Stage I gastric cancer patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
1 mg taken by mouth once a day for 14 days
A tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies.
Nagasaki University Hospital
Nagasaki, Japan
Nihon University School of Medicine
Tokyo, Japan
University of Tokyo Medical Center
Tokyo, Japan
Effectiveness of Trametinib in reversing metaplasia: changes in cell lineages
The ability of Trametinib treatment to decrease the presence of metaplastic cell lineages in biopsies of the lining of the stomach, while also allowing the return of normal cell lineages (i.e. acid-secreting parietal cells). Cell lineages will be identified by immunostaining of tissue sections from biopsies.
Time frame: About 12 months
Safety of Trametinib treatment: adverse events
Assessment of side effects induced during or after treatment with Trametinib.
Time frame: About 12 weeks
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