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 October 2016
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

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Male or female 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 August 2016.
Information provided to ClinicalTrials.gov by Taiho Pharmaceutical Co., Ltd..
Location data was received from the National Cancer Institute and was last updated in August 2016.