口服多塞塔塞尔加上恩塞奎达 - 一个第一阶段临床试验
David Wang1, Noelyn Hung2, Tak Hung3
1Department of Anaesthesia, Waikato Hospital, Hamilton, New Zealand. David.wang@waikatodhb.health.nz.
Cancer chemotherapy and pharmacology
|May 30, 2024
概括
口服多塞塔塞尔加恩塞奎达 (oDox + E) 在转移性前列腺癌患者中显示出安全的特征. 需要进一步的研究来确认多剂量疗法是否可以达到与静脉注射多塞塔塞尔相比的暴露.
科学领域:
- 药理学 药理学是指药理学的学科.
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 多塞塔克塞尔是一种抗瘤剂,由于P-glycoprotein (P-gp) 的排泄,其口服生物利用性受限.
- 口服多塞塔塞尔与肠道特异性P-gp抑制剂恩塞奎达 (oDox + E) 结合,为静脉注射提供了一个潜在的替代方案.
- 这项研究旨在评估oDox + E与IVdcetaxel相比的药理动力学暴露.
研究的目的:
- 为了确定单次口服剂量多塞塔塞尔加恩塞奎达尔 (oDox + E) 的生物可用性,安全性和耐受性.
- 为了比较oDox + E的药理动力学暴露与标准静脉注射 (IV) docetaxel.
- 在转移性前列腺癌 (mPC) 患者中评估oDox + E.
主要方法:
- 一个多中心的,第一阶段,开放标签的药理动力学试验.
- 一次剂量oDox + E (75,150,或300 mg/m2 + 15 mg) 给了mPC患者.
- 恩塞奎达 (15毫克) 于口服多塞塔塞尔一小时前给予;药物动力学暴露与IV多塞塔塞尔相比较.
主要成果:
- 口服多塞塔塞尔的暴露量随剂量增加而增加,在300 mg/m2 oDox + E时变得非线性.
- oDox + E的平均绝对生物利用率在8.19%至25.09%之间 (平均16.14%).
- 没有观察到死亡,剂量限制性毒性,严重不良事件或4级毒性;没有达到最大耐受剂量.
结论:
- oDox + E在mPC患者中显示出安全且可容忍的不良事件概况.
- 增加的口服生物可用性表明多剂量oDox + E有可能达到与IVdcetaxel可比的暴露.
- 进一步研究oDox + E的最佳多剂量方案是有必要的.
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