一项评价普那布林(BPI-2358)联合多西他赛治疗中国晚期非小细胞肺癌患者耐受性和药代动力学的I期临床试验
[Translation] A phase I clinical trial evaluating the tolerability and pharmacokinetics of Plinabulin (BPI-2358) combined with docetaxel in Chinese patients with advanced non-small cell lung cancer
主要目的:在美国I/II期临床试验基础上,确认普那布林联合多西他赛治疗中国晚期非小细胞肺癌患者的耐受性、药代动力学特征,说明BPI-2358-103试验中国人群RP3D的合理性。 次要目的:评价普那布林联合多西他赛治疗晚期非小细胞肺癌患者的初步药效反应(肿瘤疗效、预防白细胞减少)和安全性。
[Translation] Primary objective: Based on the Phase I/II clinical trial in the United States, confirm the tolerability and pharmacokinetic characteristics of Plinabulin combined with docetaxel in the treatment of Chinese patients with advanced non-small cell lung cancer, and explain the rationality of RP3D in the Chinese population of the BPI-2358-103 trial. Secondary objective: To evaluate the preliminary pharmacodynamic response (tumor efficacy, prevention of leukopenia) and safety of Plinabulin combined with docetaxel in the treatment of patients with advanced non-small cell lung cancer.
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