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

临床试验：NCI

• 批准号: 7716646
• 负责人: Stephen I Shibata
• 金额: $ 1.68万
• 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/7716646
• 关键词: Affect; Cancer Patient; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Funding; Grant; Growth; Human body; Institution; Kidney; Laboratories; Learning; Malignant Neoplasms; Multiple Myeloma; PS341 cpd; Patients; Pharmaceutical Preparations; Phase; Proteins; Purpose; Renal function; Research; Research Personnel; Resources; Safety; Source; Testing; Time; United States Food and Drug Administration; United States National Institutes of Health; cancer therapy; design; tumor

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.

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。 这项研究的目的是找出PS-341的最高和最安全的剂量，可以给予肾功能异常的人。这项研究还将发现PS-341在人体内会发生什么。 PS-341是一种实验性抗癌化合物，可阻止天然身体蛋白质的正常分解，从而减少癌症的生长和扩散。实验室测试表明，PS-341对各种不同的癌症具有活性。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有一定程度的肾功能异常，这可能会影响他们的癌症治疗，因为一些药物会被肾脏消除。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。由于骨髓瘤患者通常肾功能减退，因此了解肾功能异常患者体内对这种药物的处理非常重要。本试验旨在获得有助于为骨髓瘤患者和可能接受PS-341治疗的其他类型肿瘤患者选择适当剂量和治疗时间的信息。