评估注射用多西他赛聚合物胶束在晚期恶性实体瘤患者的耐受性和药代动力学特征的 I 期临床研究
[Translation] A phase I clinical study to evaluate the tolerability and pharmacokinetic characteristics of docetaxel polymer micelles for injection in patients with advanced malignant solid tumors
1. 评价注射用多西他赛聚合物胶束在晚期恶性实体瘤患者的安全性和耐受性。 2. 比较注射用多西他赛聚合物胶束与泰索帝注射液的 PK 相似性。 3. 获取注射用多西他赛聚合物胶束在晚期恶性实体瘤患者的药代动力学参数。 4. 比较注射用多西他赛聚合物胶束与泰索帝注射液的安全性。 5. 初步观察注射用多西他赛聚合物胶束的抗肿瘤疗效。
[Translation] 1. To evaluate the safety and tolerability of docetaxel polymer micelles for injection in patients with advanced malignant solid tumors. 2. To compare the PK similarity between docetaxel polymer micelles for injection and taxotere injection. 3. To obtain the pharmacokinetic parameters of docetaxel polymer micelles for injection in patients with advanced malignant solid tumors. 4. To compare the safety of docetaxel polymer micelles for injection and taxotere injection. 5. To preliminarily observe the anti-tumor efficacy of docetaxel polymer micelles for injection.
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