A PHASE I DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS

安全性、耐受性、药代动力学的 I 期剂量递增研究

• 批准号: 7716663
• 负责人: Ileana M. Cristea
• 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/7716663
• 关键词: Advanced Malignant Neoplasm; Biological; Clinical; Common Terminology Criteria for Adverse Events; Computer Retrieval of Information on Scientific Projects Database; Cyclophosphamide; Dose; Dose-Limiting; Drug Kinetics; Funding; Grant; Institution; Label; National Cancer Institute; Pharmaceutical Preparations; Phase; Protocols documentation; Reaction; Research; Research Personnel; Resources; Safety; Source; Toxic effect; United States National Institutes of Health; human TACSTD1 protein; human TACSTD2 protein

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. This is a multicenter, open-label, dose-escalation trial of the safety, tolerability, PK, biological and clinical activity of EMD 273066 with low-dose cyclophosphamide administered to subjects with epithelial cell adhesion molecule (EpCAM) positive advanced cancers. With some exceptions outlined in the protocol, a dose-limiting toxicity (DLT) is defined as a Grade 3 or 4 adverse drug reaction (ADR) according to National Cancer Institute Common Terminology Criteria for Adverse Events, occurring during the first cycle of administration of any dose of EMD 273066.

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。 这是一项在上皮细胞粘附分子（EpCAM）阳性晚期癌症受试者中评价EMD 273066联合低剂量环磷酰胺给药的安全性、耐受性、PK、生物学和临床活性的多中心、开放标签、剂量递增试验。除了方案中列出的一些例外情况外，剂量限制性毒性（DLT）定义为根据美国国家癌症研究所不良事件通用术语标准，在任何剂量EMD 273066的第一个给药周期期间发生的3级或4级药物不良反应（ADR）。