A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)
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.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imatinib | Small molecule | 300 mg | Oral |
| Subject | Imatinib | Small molecule | 400 mg | Oral |
| Subject | Sunitinib | Small molecule | 50 mg | Oral |
| Subject | TAS-116 | Small molecule | 80 mg | Oral |
| Subject | TAS-116 | Small molecule | 120 mg | Oral |
| Subject | TAS-116 | Small molecule | 160 mg | Oral |