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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04454476
Other study ID # VICC GI 2049
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 9, 2022
Est. completion date May 2025

Study information

Verified date September 2023
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date May 2025
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 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. Exclusion Criteria: - 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 - Severe valvular disease - <55% at present - Atrial fibrilation in ECG with BPM=>100 Laboratory values as listed below (SI units) Absolute Neutrophil Count <1.5x10A9/L (1500 per mm3) Platelets <100x10A9/L (100,000 per mm3) Hemoglobin<=9.0 g /dL Serum creatinine >1.5 X upper limit of normal (ULN) Serum bilirubin >1.5 x ULN AST or ALT > 2.5 x ULN Ophthalmological conditions as follows: Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy (CSR) or retinal vein occlusion Intraocular pressure (IOP) > 21 mmHg or uncontrolled glaucoma (irrespective of IOP) Male or female patients of reproductive potential and, as judged by the investigator, are not employing an effective method of birth control and pregnant female. Breast feeding female Have refractory nausea and vomiting , chronic gastrointestinal diseases (e.g . inflammatory bowel disease), or significant bowel resection that would adversely affect the absorption / bioavailability of the orally administered study medication. Person who has history of hyperrefractory for Trametinib methyl sulfoxide Person who has pneumonia under chest X-ray. Have evidence of any other significant clinical disorder or laboratory finding that, as judgedby the investigator, makes it undesirable for the patient to participate in the study.

Study Design


Intervention

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

Locations

Country Name City State
Japan Nagasaki University Hospital Nagasaki
Japan Nihon University School of Medicine Tokyo
Japan University of Tokyo Medical Center Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Safety of Trametinib treatment: adverse events Assessment of side effects induced during or after treatment with Trametinib. About 12 weeks
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