A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Treatments: Imatinib Mesylate; Sunitinib

Criteria

Inclusion 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

Exclusion 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)