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皮米特斯皮布在患有晚期固体瘤的患者心血管安全性:一项开放式,非随机的第一阶段研究

Katsuhiko Naoki¹, Satoshi Igawa¹, Haruki Uojima²

¹Department of Respiratory Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.

|July 10, 2024

概括

皮米特斯皮布是一种热冲击蛋白90抑制剂,在患有高级固体瘤的日本患者中没有显示出临床显著的QTc延长. 这种抗癌药物表现出可接受的安全性,具有有前途的疗效.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
心脏病学心脏病学

背景情况:

皮米特斯皮布 (TAS-116) 是一种口服,选择性热冲击蛋白90抑制剂,已在日本批准用于胃肠道瘤.
这一第一阶段研究的重点是评估皮米特斯皮布在日本患者群体中的心脏安全性.

研究的目的:

评估pimitespib在日本患者中具有晚期固体瘤的心脏安全性.
为了评估皮米特斯皮布对心率 (QTcF) 校正的QT间隔的影响.

主要方法:

这是一项开放的,非随机的多中心研究,涉及20岁或以上的日本患者.
患者接受了安慰剂,其次是皮米特斯皮布 (每天160毫克,持续5天),并采集了心电图和血液样本.
主要终点是pimitespib和安慰剂之间的QTcF与时间相匹配的差异.

主要成果:

没有观察到临床相关的QTc延长;QTcF差异的95%置信区间的上限为<20毫秒.
皮米特斯皮布的药理动力学参数与先前的数据一致,在较高的血度下没有显著的QTcF增加.
安全性概况是可以接受的,40%的人经历了3级以上的不良事件 (主要是腹). 无进展生存时间的中位数为3.1个月.

结论:

皮米特斯皮布在日本患者中没有显示出具有临床意义的QTc延长或心血管安全问题,这些患者患有耐火性,晚期固体瘤.
这项研究支持pimitespib良好的心脏安全性,并表明该患者群体有前途的抗癌作用.

关键词:

先进的固体瘤是先进的心血管安全心血管安全热冲击蛋白90 (HSP90) 抑制剂药物动力学药物动力学第1阶段第一阶段这就是pimitespibib的意思.

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