NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2011210044

Registered date:01/11/2021

A phase 1 study of pimitespib and imatinib in patients with GIST

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedGIST
Date of first enrollment01/12/2021
Target sample size78
Countries of recruitmentTaiwan,Japan,Singapore,Japan,Australia,Japan,China,Japan
Study typeInterventional
Intervention(s)Dose Escalation Part -Pimitespib in combination with imatinib Expansion Part - Arm A: pimitespib in combination with imatinib - Arm B: pimitespib followed by imatinib - Arm C: sunitinib < Pimitespib > 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. The doses in the Dose Escalation Part will be 80, 120 (starting dose), and 160 mg. The doses used in Arm A will be maximum tolerable dose (MTD) or RD based on the information, including the safety and PK data in the Dose Escalation Part. In Arm B, pimitespib will be administered with the starting dose of 160 mg daily. < Imatinib > Imatinib will be administered orally, after a meal and large glass of water QD. The doses in Dose Escalation Part will be 400 mg or 300 mg (De-escalation). The doses used in Arm A will be MTD or RD based on information, including the safety and PK data in the Dose Escalation Part. In Arm B, imatinib will be administered post after pimitespib discontinuation with the starting dose of 400 mg daily. < Sunitinib > Sunitinib will be administered orally QD with a starting dose of 50 mg, on a schedule of 4 weeks on treatment followed by 2 weeks off, and will be taken with or without a meal in Arm C.

Outcome(s)

Primary Outcome< Dose Escalation Part > Dose-limiting toxicity (DLT) and MTD of pimitespib in combination with imatinib < Expansion Part > Progression-free survival (PFS) by the independent radiological review
Secondary OutcomeAdverse event, Adverse drug reaction, Laboratory abnormalities

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria- Provided written informed consent - Histologically confirmed GIST - Progressed on the basis of imaging during or within 6 months of the last imatinib administration at enrollment - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclude criteria- Received treatment with any other line of therapy besides imatinib for advanced GIST; including local surgery and radiotherapy - A serious illness or medical condition - Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study - Pregnancy or lactation (including lactation interruption)

Related Information

Contact

Public contact
Name Naoki Arimura
Address 1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo Tokyo Japan 101-8444
Telephone +81-3-3293-2113
E-mail n-arimura@taiho.co.jp
Affiliation Taiho Pharmaceutical Co., Ltd.
Scientific contact
Name Atsushi Sato
Address 53 Honcho, Hirosaki, Aomori Aomori Japan 036-8563
Telephone +81-3-3293-2113
E-mail n-arimura@taiho.co.jp
Affiliation Hirosaki University Hospital