Pharmacokinetic Study of TAS-118 Compared with S-1
- Conditions
- Solid tumor
- Registration Number
- JPRN-jRCT2080222111
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20
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)
-Current or past severe lung disease (e.g. interstitial pneumonia, pulmonary fibrosis, or severe emphysema).
-Any other active illness such as severe (e.g. grade 3 or higher) 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.
-The diabetic patients who have poorly controlled despite the medication or severe diabetic complication.
-Grade 3 or higher serious complications (e.g. serious enteritis, serious stomatitis, gastrointestinal ulceration/hemorrhage/perforation, ileus, renal failure, nephrosis syndrome, liver failure or cerebrovascular disorder).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The plasma concentrations and each pharmacokinetic parameter.<br>Each pharmacokinetic parameter will be calculated, and be compared.
- Secondary Outcome Measures
Name Time Method -Frequency of adverse events and side effects<br>-Antitumor efficacy in a continuous administration period<br><br>-Safety: Common Terminology Criteria for Adverse Events (CTCAE)<br>-Efficacy: RECIST guideline