Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04454476|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : November 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Metaplasia Stage I Gastric Cancer Initial-onset Gastric Cancer||Drug: Trametinib treatment Procedure: Endoscopy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor Treatment|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
|Experimental: Trametinib treatment||
Drug: Trametinib treatment
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.
- Effectiveness of Trametinib in reversing metaplasia: changes in cell lineages [ Time Frame: About 12 months ]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.
- Safety of Trametinib treatment: adverse events [ Time Frame: About 12 weeks ]Assessment of side effects induced during or after treatment with Trametinib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454476
|Contact: James Goldenring, MDfirstname.lastname@example.org|
|Nihon University School of Medicine|
|Contact: Takuji Gotoda email@example.com|
|Principal Investigator: Takuji Gotoda|
|University of Tokyo Medical Center|
|Contact: Sachiyo Nomura firstname.lastname@example.org|
|Principal Investigator: Sachiyo Nomura|
|Principal Investigator:||James Goldenring, MD||Vanderbilt Medical Center|