[Translation] Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of doxycycline hydrochloride tablets in the treatment of patients with advanced solid tumors
主要目的:评价盐酸多西环素片治疗晚期恶性实体瘤患者的安全性和耐受性,并观察最大耐受剂量,确定Ⅱ期临床试验推荐剂量。 次要目的: (1)评价盐酸多西环素片在晚期恶性实体瘤患者中的药代动力学特征。 (2)按照实体瘤疗效评价标准(RECIST 1.1),通过客观缓解率和疾病控制率初步评价盐酸多西环素片的抗肿瘤疗效。
[Translation] Primary objectives: To evaluate the safety and tolerability of doxycycline hydrochloride tablets in the treatment of patients with advanced malignant solid tumors, observe the maximum tolerated dose, and determine the recommended dose for phase II clinical trials. Secondary objectives: (1) To evaluate the pharmacokinetic characteristics of doxycycline hydrochloride tablets in patients with advanced malignant solid tumors. (2) To preliminarily evaluate the anti-tumor efficacy of doxycycline hydrochloride tablets by objective response rate and disease control rate according to the solid tumor efficacy evaluation criteria (RECIST 1.1).