Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor
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|ClinicalTrials.gov Identifier: NCT04454476|
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : January 10, 2023
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|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|
|Actual Study Start Date :||November 9, 2022|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2025|
|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.
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|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
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, MDemail@example.com|
|Nihon University School of Medicine||Recruiting|
|Contact: Takuji Gotoda firstname.lastname@example.org|
|Principal Investigator: Takuji Gotoda|
|University of Tokyo Medical Center||Recruiting|
|Contact: Sachiyo Nomura email@example.com|
|Principal Investigator: Sachiyo Nomura|
|Principal Investigator:||James Goldenring, MD||Vanderbilt Medical Center|
|Responsible Party:||James Goldenring, Principal Investigator, Vanderbilt-Ingram Cancer Center|
|Other Study ID Numbers:||
VICC GI 2049
|First Posted:||July 1, 2020 Key Record Dates|
|Last Update Posted:||January 10, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
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