NCI #5874, PHI-43: "A PHASE I PHARMACOKINETIC STUDY OF PS341 IN PATIENTS WITH

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。本研究的目的是找出在肾功能异常的人中可以给予PS-341的最高和最安全的剂量。这项研究还将发现PS-341在人体内发生了什么。PS-341是一种实验性的抗癌化合物，它可以阻止自然身体蛋白质的正常分解，这可能会导致减少癌症的生长和扩散。实验室测试表明，PS-341对多种不同的癌症都有活性。FDA最近批准PS-341用于多发性骨髓瘤患者。大约一半的多发性骨髓瘤患者和大约十分之一的癌症患者都有不同程度的肾功能异常，这可能会影响他们的癌症治疗，因为一些药物会被肾脏排除。目前，关于肾功能异常患者的安全性和可能需要调整剂量的信息不足。由于骨髓瘤患者的肾功能通常会减弱，因此了解肾功能异常患者体内对这种药物的处理方式是很重要的。这项试验旨在获得有助于为骨髓瘤患者和可能使用PS-341治疗的其他类型的肿瘤患者选择适当剂量和治疗时机的信息。

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 purpose of this study is to find out the highest and safest dose of PS-341 that can be given in people with abnormal kidney function. This study will also find out what happens to PS-341 in the human body. PS-341 is an experimental anti-cancer compound that blocks the normal breakdown of natural body proteins, which may result in reducing cancer growth and spread. Laboratory tests suggest that PS-341 has activity against variety of different cancers. The FDA has recently approved PS-341 for use in patients with multiple myeloma. Approximately half of the patients with multiple myeloma, and about one out of ten of all cancer patients have some degree of abnormal kidney function, which can affect their cancer treatment because some of the drugs are eliminated by the kidney. Currently, there is insufficient information regarding the safety and possible need to adjust doses in patients with abnormal kidney function. Since myeloma patients often have diminished kidney function, it is important to learn about the body's handling of this drug in patients with abnormal kidney function. This trial is designed to obtain information that will assist in selecting the proper dose and timing of this treatment for myeloma patients and for patients with other types of tumors that might be treated with PS-341.