Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor

NCT04454476 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: VICC GI 2049
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  About 12 months

• Safety of Trametinib treatment: adverse events

  Assessment of side effects induced during or after treatment with Trametinib.

  About 12 weeks

Study Arms (1)

Trametinib treatment

EXPERIMENTAL

Drug: Trametinib treatment; Procedure: Endoscopy

Interventions

Trametinib treatment DRUG

1 mg taken by mouth once a day for 14 days

Trametinib treatment

Endoscopy PROCEDURE

A tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies.

Trametinib treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary registration
• Person having intact stomach after treatment of early gastric cancer or gastric adenoma
• Person whose treated gastric cancer histological type is intestinal type.
• Person whose treated gastric cancer or gastric adenoma was curatively resected.
• Person who does not have symptoms of gastric cancer recurrence.
• Person who can declare agreement for enrollment by understanding the study and signing the informed consent document after hearing the explanation.
• Person who can visit the hospital in accordance with the schedule.
• Secondary registration
• Person who has gastric atrophy at endoscopy.
• Person who does not have symptoms of gastric cancer recurrence by endoscopy.
• Person who has intestinal metaplasia in stomach, histologically confirmed in biopsy specimens taken under endoscopy within 8 weeks prior to taking MEK inhibitor, Trametinib.

You may not qualify if:

• Person whose treated gastric cancer was diffuse or signet ring cancer.
• Person whose treated gastric cancer or gastric adenoma was not curatively resected.
• Person who has the history of other malignant disease.
• Person who had a significant improvement in metaplasia after eradication therapy for Helicobacter pylori within one year.
• Person who had plan of eradication Helicobacter pylori in 1 year 9 months
• Person who has history of previous Trametinib or other MEK inhibitor use.
• Person who has history of hypersensitivity to excipients.
• Person who entered clinical trial and took investigational new drug within 12 weeks.
• Presence of active infection other than chronic gastritis.
• Cardiac conditions as follows:
• Uncontrolled hypertension (BP\>=150/95 mm Hg despite medical therapy)
• Acute myocardial infection within 6 months prior to starting treatment
• Uncontrolled Angina (Canadian Cardiovascular Society grade II-IV even after medication)
• Symptomatic heart failure NYHA Class II-IV
• \<45% in the past

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (3)

Nagasaki University Hospital

Nagasaki, Japan

Location

Nihon University School of Medicine

Tokyo, Japan

Location

University of Tokyo Medical Center

Tokyo, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms; Metaplasia

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• James Goldenring, MD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 1, 2020
• Study Start: November 9, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)