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Drug Highest PhasePhase 3 |
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JK1201I单次联合多次给药在小细胞肺癌患者中的安全性、耐受性及初步有效性研究
[Translation] Study on the safety, tolerability and preliminary efficacy of single combined with multiple administration of JK1201I in patients with small cell lung cancer
主要目的:
1) 评价JK1201I对小细胞肺癌患者的安全性和耐受性;
2) 确定JK1201I的剂量限制性毒性(DLT)和最大耐受剂量(MTD)。
次要目的:
1) 考察JK1201I在小细胞肺癌患者体内的药代动力学特性;
2) 观察JK1201I的初步疗效 。
[Translation] Primary objectives:
1) To evaluate the safety and tolerability of JK1201I in patients with small cell lung cancer;
2) To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of JK1201I.
Secondary objectives:
1) To investigate the pharmacokinetic properties of JK1201I in patients with small cell lung cancer;
2) To observe the preliminary efficacy of JK1201I.
注射用聚乙二醇伊立替康 单次联合多次给药用于恶性实体瘤患者的安全性、耐受性和药代动力学研究
[Translation] Safety, tolerability and pharmacokinetics of single combined with multiple doses of polyethylene glycol irinotecan for injection in patients with malignant solid tumors
主要目的为:评价注射用聚乙二醇伊立替康对恶性实体肿瘤患者的安全性和耐受性;并确定其剂量限制性毒性(DLT)和最大耐受剂量(MTD)。次要目的为:考察其在恶性实体肿瘤患者体内的药代动力学特性,并获取药代动力学参数;观察注射用聚乙二醇伊立替康的初步疗效,为后续临床试验推荐剂量和给药方式提供依据。
[Translation] The primary objectives are to evaluate the safety and tolerability of polyethylene glycol irinotecan for injection in patients with malignant solid tumors and to determine its dose-limiting toxicity (DLT) and maximum tolerated dose (MTD). The secondary objectives are to investigate its pharmacokinetic properties in patients with malignant solid tumors and obtain pharmacokinetic parameters; to observe the preliminary efficacy of polyethylene glycol irinotecan for injection and provide a basis for the recommended dose and administration method for subsequent clinical trials.
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