PHASE I CLINICAL AND PHARMACOKINETIC TRIAL OF INTRAPERITONEAL IRINOTECAN

腹腔注射伊立替康 I 期临床及药代动力学试验

• 批准号: 7716675
• 负责人: AGUSTIN A GARCIA
• 金额: $ 0.6万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716675
• 关键词: Clinical; Computer Retrieval of Information on Scientific Projects Database; Dose; Dose-Limiting; Drug Kinetics; Funding; Grant; Institution; Maximum Tolerated Dose; Phase; Phase I Clinical Trials; Research; Research Personnel; Resources; Route; Source; Toxic effect; United States National Institutes of Health; Week; intraperitoneal; irinotecan

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objectives of this Phase I trial will establish the maximum tolerated dose of Irinotecan when administered by an intraperitoneal route every three weeks. It will determine the pharmacokinetics of intraperitoneal Irinotecan and determine the toxicity profile of intraperitoneal Irinotecan. Dose levels of Irinotecan will be escalated until dose limiting toxicity is seen. Treatment is repeated every 3 weeks. This is an institutional investigator initiated trial.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项第一阶段试验的目标是确定每三周通过腹膜途径给药时伊立替康的最大耐受量。它将测定伊立替康的药代动力学，并测定伊立替康的毒性。伊立替康的剂量水平将不断上升，直到出现剂量限制性毒性。每3周重复治疗一次。 这是一个机构调查员发起的审判。