[Translation] A single-center, dose-escalation, open-label phase I clinical study of oral TG02 capsules in patients with recurrent/progressive high-grade gliomas who failed TMZ therapy
主要目标:探索剂量限制性毒性(DLT)和最大耐受剂量(MTD) 次要目标:1、评估研究药物的药代动力学参数;2、评估研究药物的心脏安全性;3、初步评估研究药物抗肿瘤的有效性。 探索性目标:探索肿瘤组织myc和mcl-1表达与临床疗效的关系。
[Translation] Primary objective: To explore dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) Secondary objectives: 1. To evaluate the pharmacokinetic parameters of the investigational drug; 2. To evaluate the cardiac safety of the investigational drug; 3. To initially evaluate the study Antitumor efficacy of drugs. Exploratory goal: To explore the relationship between the expression of myc and mcl-1 in tumor tissue and clinical efficacy.