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- W3158072177 abstract "2452 We have conducted a first in human Phase I trial using MS-275, an oral histone deacetylase inhibitor, in advanced solid tumors and lymphoma patients. The trial initially used a daily x 28, repeated every 6 weeks, dosing schedule with an accelerated titration design, beginning at 2 mg/m2 (1/10th rat maximal tolerated dose [MTD]). However, in humans the MTD was immediately exceeded at the 1st dose level with grade 3 AST, hypophosphatemia, hypoalbuminemia, pleural effusion and epigastric pain. Preliminary PK analysis suggested that the t1/2 of MS-275 in humans is substantially longer than preclinical species predicted to account for this finding. A once q14 day schedule was then implemented, starting at 2 mg/m2 with 2 mg/m2 increments. Twenty-seven patients have been enrolled on the q14 day schedule. The first course severe adverse events observed were CTC grade 3 nausea, fatigue, anorexia, and vomiting. Frequent grade 1-2 toxicities include fatigue, nausea, hypoalbuminemia, headache, thrombocytopenia, anorexia, neutropenia, and dyspepsia. The MTD was observed at 10 mg/m2 and the DLTs were nausea, anorexia and fatigue. The detailed pharmacokinetics study is underway and will be presented. Furthermore, by immunofluorescent analysis, increased histone H3 acetylation in peripheral blood mononuclear cells is apparent at all dose levels. Based on these data, a new oral schedule, weekly x 4, repeated every six weeks is presently being evaluated." @default.
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- W3158072177 date "2004-04-01" @default.
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- W3158072177 title "A first in human trial of an oral histone deacetylase inhibitor, MS-275, in advanced solid tumor and lymphoma patients." @default.
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