A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Advanced Solid Tumors
- Interventions
- Drug: TAS-114 + S-1
- Registration Number
- NCT01610479
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
- Detailed Description
This is a phase 1, open-label, non-randomized, dose-escalating safety, tolerability, and pharmacokinetic study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Life expectancy of at least 3 months
- Histological or cytological documentation of advanced solid tumors
- ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
- Adequate bone marrow, liver and renal function
- Women of childbearing potential and men must agree to use adequate contraception
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAS-114/S-1 TAS-114 + S-1 TAS-114 plus S-1
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of TAS-114 when used in combination with S-1 4 years
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, S-1 components and its metabolite) 4 years Response rate 4 years Disease control rate 4 years Progression free survival 4 years
Trial Locations
- Locations (1)
Site 01
🇯🇵Kashiwanoha, Kashiwa-shi, Chiba, Japan
Site 01🇯🇵Kashiwanoha, Kashiwa-shi, Chiba, Japan