[特洛克萨丁的临床耐受性和药理动力学]
1Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Zhonghua zhong liu za zhi [Chinese journal of oncology]
|June 24, 2023
概括
在患有晚期恶性瘤的患者中,特洛克萨巴显示出可容忍的毒性. 第二阶段试验的推剂量为6.4mg/m2 ,在43.8%的参与者中观察到稳定的疾病.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
背景情况:
- 晚期或复发的恶性瘤对标准治疗具有抗药性,这给治疗带来了重大挑战.
- 识别具有可接受安全概况的新型治疗剂对于改善患者的治疗结果至关重要.
研究的目的:
- 评估特洛克沙丁在患有晚期或复发性恶性瘤,不耐常规治疗的患者的安全性和疗效.
- 为了确定第二阶段临床试验的最大耐受剂量 (MTD) 和推剂量.
主要方法:
- 一项I期前性研究,涉及静脉注射托克沙丁的剂量升级.
- 患者每三周接受计划剂量水平 (1.8至8.0毫克/米2) 的单剂量输注.
- 通过不良事件监测来评估安全性和耐受性,中性质减退被确定为剂量限制性毒性.
主要成果:
- 纳入了19名患者,疲劳,白血病和中性质衰竭是最常见的不良事件.
- 最大的耐受剂量 (MTD) 确定为6.4mg/m.
- 观察到的最佳总体反应是43.8%的患者患有稳定疾病,其消除半衰期从15.91到76.63小时不等.
结论:
- 特洛克萨巴在这种患者群体中表现出耐受性良好的毒性特征.
- 在II期临床试验中进一步研究的推剂量为6.4mg/m.
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