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在患有晚期固体瘤的患者中,对口服计量学凝胺 (D07001) 的I期研究

Nai-Jung Chiang^1,2, Jih-Hsiang Lee³, Ming-Huang Chen^1,2

¹Department of Oncology, Taipei Veterans General Hospital, 112201 Taipei, Taiwan.

|April 22, 2025

概括

在软凝囊中增强吸收的口服凝素 (D07001) 在先进的固体瘤中证明了高达100毫克连续剂量的安全性. 液体和软凝配方之间的药理动力学是可比的,支持进一步的临床研究.

科学领域:

药理学药理学是指药理学的学科.
在瘤学瘤学.
药物开发药物开发

背景情况:

D07001-F4是一种口服格姆西塔宾配方,旨在增强吸收.
两个第一阶段研究评估了两个配方:液体 (D07001-F4) 和软凝囊 (D07001-软凝).
研究旨在确定晚期固体瘤中剂量限制毒性 (DLT),药理动力学 (PK) 和最大耐受剂量 (MTD).

研究的目的:

评估D07001-软凝囊的安全性和耐受性.
确定D07001-软凝的最大耐受剂量 (MTD).
评估口服凝素配方的药理动力学和生物可用性.

主要方法:

第一阶段研究:口服D07001-F4 (2-80毫克) 的剂量升级.
第1b期研究:D07001-软凝囊 (40-120毫克) 用于耐药性胃肠恶性瘤患者.
在PK分析中,不同配方的gemcitabine及其代谢物水平进行了比较.

主要成果:

口服D07001-F4的平均生物利用率约为39%.
确定D07001-软凝的MTD为100毫克,剂量限制性毒性包括肝毒性和厌食症在120毫克时.
凝和代谢物暴露 (Cmax,AUC) 显示了剂量依赖性和配方之间的可比性.

结论:

在先进的固体瘤中,D07001-软凝囊可以安全地连续服用高达100毫克的剂量.
可以比较的PK配置文件支持使用D07001-软凝作为口服凝替代品.
建议进行进一步的研究,以确定组合疗法的最佳剂量.

关键词:

D07001 一个人的生活.剂量限制性毒性有限性最大的可容忍剂量.通过口服使用的gemcitabine.药物动力学药物动力学固体瘤是一种固体瘤.

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