PHASE I TRIAL AND PHARMACOKINETIC STUDY OF CARMUSTINE AND TEMOZOLOMIDE

卡莫司汀和替莫唑胺的 I 期试验和药代动力学研究

• 批准号: 6275794
• 负责人: MICHAEL BOZIK
• 金额: $ 1.91万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275794
• 关键词: antineoplastics; carmustine; central nervous system neoplasms; clinical research; clinical trial phase I; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; pharmacokinetics

This is a phase I pharmacokinetic (PK) study of carmustine (BCNU) & temozolomide in patients with CNS tumors. It is anticipated that 10 patients will enter this study at the UPCI. PK will be performed during the first cycle of therapy of both arms of the study at all dose levels. The primary endpoint of the study will be determination of the MTD of temozolomide plus BCNU for each schedule.

这是卡莫司汀(BCNU)的I期药代动力学(PK)研究。 替莫唑胺治疗中枢神经系统肿瘤预计将有10个 患者将在UPCI进入这项研究。将在以下时间执行PK 研究的两个分支在所有剂量水平下的第一个治疗周期。 这项研究的主要终点将是确定 替莫唑胺加BCNU各疗程。