Food effect and dosage form comparison study of TAS-118

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 40 人开始时间: 2013年12月17日最近更新: 2023年10月17日

试验速览

暂无简介。

•Written consent to participate as a subject in this clinical study.
•-Capable of oral intake.
•-Histologically or cytologically confirmed to be a solid tumor.
•-Standard therapies are ineffective, or there is no generally accepted standard treatment.
•-At least 20 years of age at the time of informed consent.
•-Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.

•-Unmanageable Diarrhea (e.g. watery stool, difficulty in controlling bowel movements despite the medication, grade 2 or higher, 5 stools or more per day).
•-Current or past severe lung disease (e.g. interstitial pneumonia, pulmonary fibrosis, or severe emphysema).
•-Any other active illness such as severe cardiac disease (e.g. myocardial infarction, angina pectoris, arrhythmia, or cardiac failure) that would preclude safe administration of study therapy at the time of randomization. Any of the following events within the 6 months prior to randomization: any episode of myocardial infarction or angina pectoris. QTc interval was >= 450 msec.
•-The diabetic patients who have poorly controlled despite the medication or severe diabetic complication.
•-Serious complications (e.g. serious enteritis, serious stomatitis, gastrointestinal ulceration/hemorrhage/perforation, ileus, renal failure, nephrosis syndrome, liver failure or cerebrovascular disorder).

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