Expanded access program of TAS-116 (pimitespib) in patients with GIST

Expanded access program of TAS-116 (pimitespib) in patients with advanced gastrointestinal stromal tumor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210526

Enrollment

Registered

2022-02-01

Start date

2022-02-22

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

Pimitespib will be administered orally in 5 consecutive days followed by 2 days off treatment on an empty stomach at least 1 hour before or 2 hours after a meal. Pimitespib will be administered with t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Provided written informed consent - Histologically confirmed GIST - Imatinib, sunitinib and regorafenib as prior treatment and a history of RECIST PD or Clinical PD or intolerance to the most recent previous these treatments. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion criteria

Exclusion criteria: - Corrected visual acuity < 0.5 (using the International Visual Acuity Measurement Standard) for both eyes - A serious illness or medical condition - Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
- Adverse event, Adverse drug reaction - Vital signs, Laboratory abnormalities - ECG	—

Contacts

Public ContactArimura Naoki

Taiho Pharmaceutical Co., Ltd.

n-arimura@taiho.co.jp+81-3-3293-2113

Outcome results

None listed

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