PS-341 IN PATIENTS WITH ADVANCED MALIGNANCIES AND RENAL DYSFUNCTION

PS-341 用于晚期恶性肿瘤和肾功能不全的患者

• 批准号: 7378050
• 负责人: Scot C Remick
• 金额: $ 0.82万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378050
• 关键词: PS; 341; PATIENTS; ADVANCED; MALIGNANCIES

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 multi-center, Phase I study of the CTEP-sponsored Organ Dysfunction Working Group. The objectives of this study are to: 1) identify the pharmacokinetic and pharmacodynamic profile of PS-341 in patients with advanced malignancy and mild, moderate or severe renal insufficiency, and 2) evaluate the safety, tolerability, and the maximum tolerated dose of PS-341 for patients with varying degrees of renal insufficiency. Subjects will be divided into 5 treatment groups based on creatinine clearance measurements. Each group will have a different starting dose of PS-341. Subjects will receive PS-341 through an IV infusion of normal saline over 30 minutes on Days 1, 4, 8 and 11, followed by a week without treatment. One cycle is 21 days and cycles may be repeated until disease progression. During Cycle 1 only, subjects will receive treatment at the GCRC and pharmacokinetic samples will be drawn. Doses will be increased according to the dose escalation plan detailed in the protocol. Doses will not be escalated in any individual patient. This study will enroll a total of approximately 69 subjects at 11 U.S. medical centers (10 subjects are expected at this site).

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项由CTEP申办的器官功能障碍工作组开展的多中心I期研究。本研究的目的是：1）确定PS-341在晚期恶性肿瘤和轻度、中度或重度肾功能不全患者中的药代动力学和药效学特征，2）评价PS-341在不同程度肾功能不全患者中的安全性、耐受性和最大耐受剂量。根据肌酐清除率测量值将受试者分为5个治疗组。每组将有不同的PS-341起始剂量。受试者将在第1、4、8和11天通过静脉输注生理盐水30分钟接受PS-341，随后一周不接受治疗。一个周期为21天，可以重复一个周期，直到疾病进展。仅在周期1期间，受试者将在GCRC接受治疗，并将采集药代动力学样本。将根据方案中详述的剂量递增计划增加剂量。任何个体患者的剂量均不会递增。本研究将在11家美国医学中心共入组约69例受试者（该研究中心预计有10例受试者）。