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:
Participant gender:
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.