Treatment for gastric mucosal metaplasia with MEK inhibitor

JRCT ID: jRCTs031200052

Registered date:17/06/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients having gastric mucosal metaplasia after treatment for early gastric cancer or adenoma
• Date of first enrollment: 09/11/2022
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Using Trametinib for other disease than approved disease

Outcome(s)

Primary Outcome

Determine whether Trametinib treatment can significantly ameliorate the presence of
metaplastic lineages in the stomach and allow repopulation of the gastric mucosa with normal
gastric lineages in treating patients 4 weeks +- 1 week after treatment (more than 50% compared to pre-treatment).

Secondary Outcome

1, Determine whether Trametinib treatment can significantly ameliorate the presence of
metaplastic lineages in the stomach and allow repopulation of the gastric mucosa with normal
gastric lineages in treating patients 12 months +- 6 monthsafter treatment (more than 50% compared to pre-treatment).
2, Safty evaluation of Trametinb 1 mg/day for 2 weeks treatment. For the safety evaluation, NCI-CTCAE grade will be used. For substantial safety evaluation, the emergence rate of rash, diarhea, cardiac functional failure, hepatic failure will be evaluate.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Getting agreement and first registering
(1) Person having stomach after treatment of early gastric cancer or gastric adenoma
(2) Person whose treated gastric caner histological type was intestinal
(3) Person whose treated gastric cancer or gastric adenoma was curatively resected
(4) Person who does not have symptoms of gastric cancer recurrence
(5) Person who is 20 years or older
(6) Both sexes
(7) Person who can declare agreement for registering by understanding the study and signing the document after hearing the explanation
(8) Person who can visit the hospital in accordance to the schedule

2) Second registering
(1) Person who has gastric atrophy under endoscopy
(2) Person who does not have symptoms of gastric cancer recurrence
(3) Person who has intestinal metaplasia in stomach, histologically confirmed in biopsy specimens taken under endoscopy within 8 weeks prior to taking MEK inhibitor, Trametinib.

Exclude criteria

Person who matches one of the criteria below is excluded.
(1) Person whose treated gastric cancer was diffuse or signet ring cancer.
(2) Person whose treated gastric cancer or gastric adenoma was not curatively resected
(3) Person who has the history of other malignant disease
(4) Person who secceeded eradication therapy for Helicobacter pylori within one year
(5) Person who had plan of eradication Helicobacter pylori in 1 year 9 months
(6) Person who has history of previous Trametinib or other MEK inhibitor use.
(7) Person who has history of hypersensitivity to excipients.
(8) Person who enterd clinical trial and took investigational new drug within 12 weeks
(9) Presence of active infection other than chronic gastritis.
(10) Cardiac conditions as follows:
a. Uncontrolled hypertension (BP>=150/95 mmHg despite medical therapy)
b. Acute myocardial infection within 6 months prior to starting treatment
c. Uncontrolled Angina (Csnsdian Cardiovascular Society grade II-IV even after medication)
d. Symptomatic heart failure NYHA Class II-IV
e. LVEF<45% in the past
f. Severe vulver disease
g. LVEF<55% in present
h. Atrial fibrilation in ECG with BPM=>100
Laboratory values as listed below (SI units)
(11) Absolute Neutrophil Count <1.5x10^9/L (1500 per mm^3)
(12) Platelets <100x10^9/L (100,000 per mm^3)
(13) Haemoglobin<=9.0 g/dL
(14) Serum creatinine >1.5 X upper limit of normal (ULN)
(15) Serum bilirubin >1.5 x ULN
(16) AST or ALT > 2.5 x ULN
(17) Ophthalmological conditions as follows
a. Current or past history of retinal pigment epithelial detachment (RPED)/central serous
retinopathy (CSR) or retinal vein occlusion
b. Intraocular pressure (IOP) > 21 mmHg or uncontrolled glaucoma (irrespective of IOP)
(18) 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.
(19) Breast feeding female
(20) 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.
(21) Person who has history of hyperrefractory for Trametinib methyl sulfoxide
(22) Person who has pneumonia under chest X-ray.
(22) Have evidence of any other significant clinical disorder or laboratory finding that, as judged
by the investigator, makes it undesirable for the patient to participate in the study.

Related Information

• Primary Sponsor: Yagi Koichi
• Secondary Sponsor: Goldenring R James
• Source(s) of Monetary Support: Nobelpharma Co., Ltd.