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

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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.