NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Solid tumor
Date of first enrollment	17/12/2013
Target sample size	40
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : TAS-118 INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : (Food effect study)TAS-118 will be administered orally after breakfast or under fasting once per day at the 1st or the 2nd administration. Generic name etc : TAS-118 INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : (Dosage form comparison study)TAS-118 or S-1/LV will be administered orally under fasting once per day at the 1st or the 2nd administration. control material(s) Generic name etc : S-1, LV INN of investigational material : S-1:Tegafur, gimeracil, oteracil LV:folic acid Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : (Dosage form comparison study)S-1/LV will be administered orally under fasting once per day at the 1st or the 2nd administration.

Outcome(s)

Primary Outcome	The plasma concentrations and each pharmacokinetic parameter. Each pharmacokinetic parameter will be calculated, and be compared.
Secondary Outcome	-Frequency of adverse events and adverse drug reactions. -Antitumor efficacy in a continuous administration period etc -Safety: Common Terminology Criteria for Adverse Events (CTCAE) -Efficacy: RECIST guideline

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	-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.
Exclude criteria	-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).