CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 120 enrolled
Drug / intervention
TAS-114 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02454062
NCT02454062Phase 1Completed

A Phase I, 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

Taiho Oncology, Inc.·interventional·Posted May 27, 2015·Updated Sep 4, 2024

In Brief

A Phase 1 clinical trial evaluating TAS-114 and S-1 for Advanced Solid Tumors. Completed, enrolled 120 participants across 5 sites in 4 countries.

Detailed Summary

A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety, Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1 in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Italy, Switzerland
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 27, 2015
Enrollment StartMar 1, 2013
Primary CompletionDec 27, 2016
Study CompletionSep 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.1 years ago

Interventions

TAS-114drug

TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.

S-1drug

S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)