PHI-50 PHASE I AND PHARMACOKINETICS STUDY OF VIRINOSTAT FOR SOLID TUMORS AND

Virinostat 治疗实体瘤的 PHI-50 I 期和药代动力学研究

• 批准号: 7982136
• 负责人: HEINZ JOSEF LENZ
• 金额: $ 1.51万
• 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: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7982136
• 关键词: Child; Classification; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Functional disorder; Funding; Grant; Hepatic; Institution; Oral; Patients; Phase; Phase I Clinical Trials; Plasma; Recommendation; Research; Research Personnel; Resources; Solid Neoplasm; Source; Toxic effect; United States National Institutes of Health; Vorinostat; response; 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. This is a phase I study using oral vorinostat. The primary objective of the part 1 of the study is to determine the pharmacokinetic disposition of vorinostat in patients with varying degrees of hepatic dysfunction following a single oral dose of 400mg. The primary objectives of the part II of the study are to determine MTD and DLT in patients with variying degrees of heptic dysfunction in order to provide appropriated dosing recommendations for such patients. Secondary objectives will be to document toxicities, determine the association of the Child-Pugh classification with observed toxicities, plasma PK and PD's. Tumor response will be assessed also.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是我使用口服涡流调节剂进行研究的一个阶段。该研究第1部分的主要目的是确定单剂量口服400毫克后不同程度肝功能障碍患者服用伏立诺的药代动力学特征。本研究第二部分的主要目的是确定不同程度肝功能障碍患者的MTD和DLT，以便为这类患者提供适当的剂量建议。次要目标将是记录毒性，确定Child-Pugh分类与观察到的毒性、血浆PK和PD的关联。还将评估肿瘤反应。