GIST患者におけるピミテスピブとイマチニブの併用試験（CHAPTER-GIST-101）

基本情報

NCT ID

NCT05245968

ステータス

実施中（募集終了）

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

78

治験依頼者名

Taiho Pharmaceutical Co., Ltd.

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)