JPRN-jRCT2041200071已完成2 期
Phase II trial evaluating safety and efficacy of ME2136 combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy
Yasui Hirofumi0 个研究点目标入组 40 人开始时间: 2020年12月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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 <= 75age old（—）
- 性别
- All
入选标准
- •[Common factors to DM cohort and non-DM cohort both]
- •(1) Regardless of gender
- •(2) Patients scheduled to receive CDDP (CDDP >=50 mg/m2) for the first time (Those who are to take divided doses are not eligible.)
- •(3) Aged 20 years or older and 75 years or younger on the day of the registration
- •(4) ECOG PS <=1
- •(5) Not using any of the following concomitant medications within 48 hours before enrollment: NK1 receptor antagonist, 5-HT3 receptor antagonist, anti-dopamine drug, phenothiazine drug, antihistamine drug, benzodiazepine drug, barbituric acid drug
- •(6) Patients who have signed on the informed consent regarding participation in this trial
- •(7) Patients judged by the investigator as having the organs functioning fine and general conditions acceptable for safe performance of HEC
- •(8) Patients who can be hospitalized up to 120 hours after administration of CDDP
- •(9) Patients who have agreed on keeping the symptom diary during the clinical trial
- •[Factor eligible for DM cohort only]
- •At least one of the following three (10 to 12) should be satisfied.
- •(10) Diagnosed with type 2 diabetes in the past and currently taking oral hypoglycemic drugs or insulin for the treatment. HbA1c <8.0% (NGSP value) and fasting blood glucose <250 mg/dl or any time blood glucose <300 mg/dl in pre-registration examination. The fasting blood glucose is defined as the blood glucose level measured in the fasted state after fasting for 10 hours or longer.
- •(11) 126 mg/dl <=fasting blood glucose <250 mg /dl and 6.5% <= HbA1c <8.0% (NGSP value) in pre-registration tests
- •(12) 200 mg/dl <= blood glucose <300 mg/dl and 6.5% <=HbA1c <8.0% (NGSP value) in pre-registration tests
排除标准
- •[Common factors to DM cohort and non-DM cohort both]
- •(1) Patients with a history of allergy to ME2136 and similar compounds
- •(2) Patients with type 1 diabetes
- •(3) Patients with nausea that requires treatment with antiemetics at the time of enrollment, or with such symptoms as vomiting (including dry vomiting) and nausea due to opioids or underlying diseases
- •(4) Patients with one (or more) of the following diseases within 6 months before enrollment: unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, or active gastric/duodenal ulcer.
- •(5) Patients with convulsive disorders that require anticonvulsant treatment
- •(6) Patients with symptomatic brain metastases or cancerous meningitis
- •(7) Patients with pleural effusion or ascites retention that require therapeutic puncture
- •(8) Patients with pharyngeal stenosis or gastrointestinal transit disorder (esophageal/gastric pyloric stenosis, intestinal obstruction, etc.) who have difficulty in eating any food more solid than porridge
- •(9) Female patients who are pregnant, breastfeeding, or wish to become pregnant, or male patients who wish to get their partners pregnant; patients with no intentions of contraception
- •(10) Patients who have mental illness or symptoms that interfere with daily life and are considered to be difficult to participate in this trial
- •(11) Patients who received or are scheduled to receive radiation therapy to the abdomen (caudal to the diaphragm) or pelvis within 6 days before the start of the treatment and within 6 days after the start of the treatment. However, (chemo)radiation therapy for the abdomen up above the diaphragm, chest, and neck is admitted.
- •(12) Patients who may not be able to undergo standard antiemetic therapy for some reason
- •(13) Patients who are judged to be inappropriate for participation in this trial by the investigator
- •[Factors eligible for non-DM cohort only]
- •Any of the following three (14 to 16) should be satisfied.
- •(14) Patients previously diagnosed with type 2 diabetes and currently treated with oral hypoglycemic drugs or insulin
- •(15) In the pre-registration test, fasting blood glucose is >=126 mg/dl and HbA1c >=6.5% (NGSP value). The fasting blood glucose is defined as the blood glucose level measured in the fasted state after fasting for 10 hours or longer.
- •(16) Blood glucose level >= 200 mg/dl and HbA1c >= 6.5% (NGSP value) at any time in pre-registration tests
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