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

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的研究机构。 这是一项使用口服伏立诺他的I期研究。本研究第1部分的主要目的是确定不同程度肝功能障碍患者单次口服400 mg后伏立诺他的药代动力学分布。本研究第II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，以便为此类患者提供适当的给药建议。次要目的是记录毒性，确定Child-Pugh分级与观察到的毒性、血浆PK和PD的相关性。还将评估肿瘤缓解。

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.