A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01610479

Enrollment

120

Registered

2012-06-04

Start date

2012-06-30

Completion date

2017-02-28

Last updated

2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

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.

Interventions

DRUGTAS-114 + S-1

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026