RSR13 ADMINISTERED TO PATIENTS RECEIVING CRANIAL RADIATION THERAPY

一项旨在评估接受多形性胶质母细胞瘤颅脑放射治疗的患者每日重复静脉注射RSR13的有效性和安全性的II期研究“是一项对接受常规六周疗程的多形性胶质母细胞瘤颅脑放射治疗的患者进行的非随机、开放标签、多中心的疗效和安全性研究。要有资格进入这项研究，患者必须有经组织学证实的幕上IV级星形细胞瘤(多形性胶质母细胞瘤)。RSR-13的每日剂量为100毫克/公斤，浓度为20毫克/毫升，通过中心静脉进入装置在30分钟内给药。RSR-13给药将在放射治疗的第一天开始，每天都会发生，并进行计时，以便在放射治疗开始后30分钟内结束输液。在剂量和放射治疗期间，直到疾病进展或死亡，患者都将接受安全性、不良事件和毒性评估。本研究的目的是确定RSR13每日多次静脉滴注的疗效、安全性、药代动力学和药效学，RSR13在放射治疗前立即给予治疗相关的每日剂量(100 mg/dg)。

A phase II study to evaluated the efficacy and safety of repetitive daily intravenous doses of RSR13 administered to patients receiving cranial radiation therapy for glioblastoma multiforme" is a non-randomized, open-label, multi-center efficacy and safety study in patients receiving a conventional six-week course of cranial radiation therapy for glioblastoma multiforme. To be eligible for entry into the study, patients must have a histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme). The daily dose of RSR-13 will be 100 mg/kg at a concentration of 20 mg/mL administered over 30 minutes via a central venous access device. RSR-13 administration will begin on the first day of radiation therapy, occur every day of radiation therapy, and be timed so that the end of infusion occurs within 30 minutes of the start of radiation therapy. Patients will be assessed for safety, adverse events, and toxicities throughout dosing and radiation therapy and until progression of disease or death. The purpose of this study is to determine the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple daily IV infusions of RSR13 at a therapeutically relevant daily dose (100 mg/dg) administered immediately prior to radiation therapy in patients with glioblastoma multiforme.