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) studied | GIST |
Date of first enrollment | 01/12/2021 |
Target sample size | 78 |
Countries of recruitment | Taiwan,Japan,Singapore,Japan,Australia,Japan,China,Japan |
Study type | Interventional |
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 Outcome | Adverse event, Adverse drug reaction, Laboratory abnormalities |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
---|---|
Age maximum | Not applicable |
Gender | Both |
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
Primary Sponsor | Sato Atsushi |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Naoki Arimura |
Address | 1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo Tokyo Japan 101-8444 |
Telephone | +81-3-3293-2113 |
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 |
n-arimura@taiho.co.jp | |
Affiliation | Hirosaki University Hospital |