[Translation] A phase II clinical study evaluating the safety, tolerability, preliminary efficacy, and pharmacokinetics of montelukast sodium gel in patients with acute radiation-induced rectal injury.
主要目的:(1)评价孟鲁司特钠凝胶直肠给药在RARI患者中的安全性和耐受性。(2)基于主要疗效终点【采用放射治疗肿瘤组(RTOG)/欧洲癌症研究与治疗组织(EORTC)急性放射损伤分级标准,各访视直肠损伤症状严重性自基线的变化】评估孟鲁司特钠凝胶直肠给药在RARI患者中的初步疗效。
次要目的:(1)评估孟鲁司特钠凝胶直肠给药在 RARI 患者中的 PK 特征以及剂量-暴露-效应关系(如适用);(2)基于其他疗效终点评估孟鲁司特钠凝胶直肠给药在RARI患者中的初步疗效。
[Translation] Main objectives: (1) To evaluate the safety and tolerability of rectal administration of montelukast sodium gel in patients with RARI. (2) Montelukast was evaluated based on the primary efficacy endpoint [using the Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Acute Radiation Injury Grading Criteria, changes in the severity of rectal injury symptoms at each visit] Preliminary efficacy of rectal administration of sodium gel in patients with RARI.
Secondary objectives: (1) To evaluate the PK profile and dose-exposure-effect relationship (if applicable) of rectal administration of montelukast sodium gel in patients with RARI; (2) To evaluate montelukast sodium based on other efficacy endpoints Preliminary efficacy of rectal administration of gel in patients with RARI.