This trial is active, not recruiting.

Condition advanced solid tumors
Treatment tas-114 + s-1
Phase phase 1
Sponsor Taiho Pharmaceutical Co., Ltd.
Start date June 2012
End date August 2017
Trial size 120 participants
Trial identifier NCT01610479, Taiho10050020


This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
TAS-114 plus S-1
tas-114 + s-1

Primary Outcomes

Maximum tolerated dose of TAS-114 when used in combination with S-1
time frame: 4 years

Secondary Outcomes

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)
time frame: 4 years
Response rate
time frame: 4 years
Disease control rate
time frame: 4 years
Progression free survival
time frame: 4 years

Eligibility Criteria

All participants at least 20 years old.

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

Additional Information

Official title A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Taiho Pharmaceutical Co., Ltd..