A phase I study of Taiho Pharmaceutical Co., Ltd.

An Open-label, Crossover Study to Compare Different Formulations and to Evaluate Effect of Food on Pharmacokinetics of TAS-116 in Patients with Advanced Solid Tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224130

Enrollment

Registered

2018-11-05

Start date

2019-01-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Solid tumor

Interventions

investigational material(s) Generic name etc : TAS-116 Formulation A INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria - Provided written informed consent - Histologically or cytologically confirmed solid tumor. - Has a lack of response to conventional therapy or no availability of generally acknowledged standard therapy - Is able to take medications orally and to eat meals enough - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Women of childbearing potential must have a negative pregnancy test at baseline.

Exclusion criteria

Exclusion criteria: Key exclusion criteria - Has gastrointestinal dysfunction (eg, history of gastrectomy, including a little gastrectomy) that may markedly interfere with the absorption of TAS-116 - Has a serious illness or medical condition - Women who are pregnant, breastfeeding

Design outcomes

Primary

Measure	Time frame
pharmacokinetics PK parameter Comparison of each PK parameter of TAS-116 (Cmax, AUClast, and AUCinf).	—

Secondary

Measure	Time frame
safety efficacy Safety, Efficacy CTCAE Version 4.03 , RECIST Version 1.1	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026