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A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)
Sponsor: Taiho Pharmaceutical Co., Ltd.
Summary
This study consists of Dose escalation part and Expansion part. In Dose Escalation Part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. Expansion part consists of 3 arms. In Arm A, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with GIST who have failed imatinib at doses below the MTD determined in Dose Escalation Part. In Arm B, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. In Arm C, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.
Official title: A Phase 1 Study of TAS-116 (Pimitespib) in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2021-12-01
Completion Date
2026-12
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
Pimitespib
Pimitespib will be administered orally in 5 consecutive days followed by 2 days off treatment (QD 5) 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 MTD or recommended dose (RD) based on the information, including the safety and the pharmacokinetics (PK) data in the Dose Escalation Part. In Expansion Part-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 Expansion Part-A will be MTD or RD based on information, including the safety and PK data in the Dose Escalation Part. In Expansion Part-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 Expansion Part-C.
Locations (14)
Flinders Medical Center
Adelaide, Australia
Alfred Health
Melbourne, Australia
Beijing Cancer Hospital
Beijing, China
Fudan University, Shanghai Cancer Center
Shanghai, China
National Cancer Center Hospital East
Chiba, Japan
Hokkaido University Hospital
Hokkaido, Japan
Kumamoto University Hospital
Kumamoto, Japan
Osaka University Hospital
Osaka, Japan
National Cancer Center Hospital
Tokyo, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
National University Cancer Institute
Singapore, Singapore
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Linkou Chang Gung Memorial Hospital
Linkou District, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan