A phase I study of Taiho Pharmaceutical Co., Ltd.
- Conditions
- Solid tumor
- Registration Number
- JPRN-jRCT2080224130
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Bioequivalence of the two formulations was unconfirmed. Systemic exposure of Formulation A was approximately 20% less than Formulation B. A high-fat/calorie meal increased the relative pharmacokinetics and bioavailability of a single 160-mg dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
Key inclusion criteria
- Provided written informed consent
- Histologically or cytologically confirmed solid tumor.
- Has a lack of response to conventional therapy or no availability of generally acknowledged standard therapy
- Is able to take medications orally and to eat meals enough
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Women of childbearing potential must have a negative pregnancy test at baseline.
Key exclusion criteria
- Has gastrointestinal dysfunction (eg, history of gastrectomy, including a little gastrectomy) that may markedly interfere with the absorption of TAS-116
- Has a serious illness or medical condition
- Women who are pregnant, breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>PK parameter<br>Comparison of each PK parameter of TAS-116 (Cmax, AUClast, and AUCinf).
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety, Efficacy<br>CTCAE Version 4.03 , RECIST Version 1.1