A phase 2 study of TAS-116 in patients with GIST.

A PHASE 2, OPEN LABEL, SINGLE-ARM STUDY TO ASSESS THE SAFETY AND EFFICACY OF TAS-116 IN PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMORS (GIST) AFTER DISEASE PROGRESSION ON, OR INTOLERANCE TO IMATINIB, SUNITINIB AND REGORAFENIB

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223127

Enrollment

Registered

2016-03-03

Start date

2016-05-12

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

GIST

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria - Provided written informed consent - Histologically confirmed GIST. - Have had previous treatments of imatinib, sunitinb and regorafenib - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion criteria

Exclusion criteria: Key exclusion criteria - A serious illness or medical condition - Previous or concurrent cancer that is distinct in primary disease or histology from the cancer that is being evaluated in this study. (Cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia and any previous cancer curatively treated more than 5 years before the enrollment can be eligible.) - Pregnant or lactating female (including the cessation of lactation) or females of child-bearing potential who have a positive pregnancy test proceeded during the Baseline Period.

Design outcomes

Primary

Measure	Time frame
efficacy Efficacy RECIST(Ver.1.1)	—

Secondary

Measure	Time frame
safety pharmacokinetics pharmacogenomics Safety, Pharmacokinetics, Pharmacogenomics CTCAE(Ver.4.03)	—

Countries

Japan

Outcome results

None listed

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