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: 7603899
• 负责人: AGUSTIN A GARCIA
• 金额: $ 0.48万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603899
• 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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本I期试验的目的是确定每三周通过腹膜内途径给药时伊立替康的最大耐受剂量。 其将确定腹膜内伊立替康的药代动力学，并确定腹膜内伊立替康的毒性特征。 将递增伊立替康的剂量水平，直至观察到剂量限制性毒性。 治疗每3周重复一次。 这是一项机构研究者发起的试验。