Phase I Study of TAS-116 in Patients with Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Patients with advanced solid tumor
- Registration Number
- JPRN-jRCT2080222394
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Three oral dosing schedules, QD, QD x 5, and QOD of TAS-116 were evaluated in this first in human phase 1 study, and dosing regimens were identified for further development with promising preliminary clinical activities and safety profiles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
Signed, written informed consent.
- Histologically or cytologically confirmed solid tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion Criteria
- Investigational drug therapy within 21 days prior to enrollment.
- Radiotherapy within 21 days prior to enrollment.
- Received extensive prior radiotherapy on more than 30% of bone marrow.
- Females who are pregnant or breastfeeding.
- Serious complications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety<br>CTCAE (ver.4.03)
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>Pharmacokinetics, Efficacy<br>RECIST (ver.1.1)