Clinical trial: Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor (NCT04454476)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Contradiction