[Translation] A single-center, open-label, dose-escalation phase I clinical trial evaluating the safety, tolerability, and pharmacokinetics of paclitaxel polymer micelles for injection
主要目的:评价注射用紫杉醇聚合物胶束用于中国晚期实体瘤患者的安全性和耐受性,确定剂量限制性毒性(DLT)及最大耐受剂量(MTD),确定后期临床试验推荐剂量,并为后期临床试验制定给药方案提供依据,同时考察注射用紫杉醇聚合物胶束的药代动力学特征。次要目的:初步评价注射用紫杉醇聚合物胶束治疗晚期实体瘤的抗肿瘤疗效。
[Translation] Main purpose: To evaluate the safety and tolerability of paclitaxel polymer micelles for injection in Chinese patients with advanced solid tumors, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), and to determine the recommended dose in late-stage clinical trials, And to provide the basis for the formulation of the dosing regimen for the later clinical trials, and to investigate the pharmacokinetic characteristics of the paclitaxel polymer micelles for injection. Secondary objective: To preliminarily evaluate the antitumor efficacy of paclitaxel polymer micelles for injection in the treatment of advanced solid tumors.