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

JRCT ID: jRCT2041200071

Registered date:10/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Solid cancer
• Date of first enrollment: 15/12/2020
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Administer ME2136 sublingually once a day after dinner for 4 days from day 1 to day 4 of the CDDP administration.

(It can be administered even if dinner cannot be taken due to anorexia triggered by CDDP.)

Outcome(s)

• Primary Outcome: Complete response in the delayed phase

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

[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

Exclude criteria

[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

Related Information

• Primary Sponsor: Yasui Hirofumi
• Source(s) of Monetary Support: Meiji Seika Pharma Co.,Ltd.