尼洛替尼与帕克利塔塞尔联合在患有高级固体瘤的患者中进行的一期研究
Sarah J Shin1, Geraldine O'Sullivan Coyne2, Shivaani Kummar3
1National Cancer Institute, Bethesda, MD, United States.
概括
这项研究确定了尼洛尼和帕克利塔塞尔联合治疗固体瘤的最大耐受剂量. 这种组合在成年卵巢颗粒细胞瘤中显示出有希望的持续反应.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 固体瘤在癌症治疗中是一个重大挑战.
- 正在探索组合疗法以提高疗效和克服耐药性.
研究的目的:
- 评估尼洛尼布-帕克利塔塞尔组合在患有固体瘤的患者的安全性,耐受性和疗效.
- 为了确定该组合治疗的推第二阶段剂量 (RP2D).
主要方法:
- 在44名患有固体瘤的患者中使用了3+3剂量升级设计.
- 尼洛丁尼是每天口服两次,帕克利塔塞尔是静脉注射.
- 药理动力学生物标志物被评估在瘤活检和循环瘤细胞在RP2D.
主要成果:
- 确定的RP2D是每天两次300毫克尼洛尼和80毫克/米2的帕克利塔塞尔.
- 剂量限制性毒性包括4级中性质减退和3级皮疹,光敏感性和转氨酶升高.
- 三名患者获得确认的部分反应 (cPR),其中两名患有长期反应的成年卵巢粒状细胞瘤 (AOGCT).
结论:
- 尼洛丁基-帕克利塔塞尔组合具有确定的最大耐受剂量,并且在AOGCT中显示持续有效性的潜力.
- 药理动力学分析为药物组合的作用机制提供了洞察力.
- 观察到的外围神经病变率表明这种组合可能会提高耐受性.
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