JPRN-jRCTs031200052进行中（未招募）1 期
MEK Inhibitor (Trametinib) Treatment to Reverse Metaplasia in Gastric Mucosa After Treatment for Early Gastric Cancer or Gastric Adenoma
Yagi Koichi0 个研究点目标入组 15 人开始时间: 2020年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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