biostudies-literatureYeo WNCI NIH HHS3361-7https://www.ebi.ac.uk/biostudies/studies/S-EPMC3438233biostudies-literatureUnknown30(27)<h4>Purpose</h4>Epigenetic aberrations have been reported in hepatocellular carcinoma (HCC). In this study of patients with unresectable HCC and chronic liver disease, epigenetic therapy with the histone deacetylase inhibitor belinostat was assessed. The objectives were to determine dose-limiting toxicity and maximum-tolerated dose (MTD), to assess pharmacokinetics in phase I, and to assess activity of and explore potential biomarkers for response in phase II.<h4>Patients and methods</h4>Major eligibility criteria included histologically confirmed unresectable HCC, European Cooperative Oncology Group performance score ≤ 2, and adequate organ function. Phase I consisted of 18 patients; belinostat was given intravenously once per day on days 1 to 5 every 3 weeks; dose levels were 600 mg/m(2)Journal of clinical oncology : official journal of the American Society of Clinical OncologyEpigenetic therapy using belinostat for patients with unresectable hepatocellular carcinoma: a multicenter phase I/II study with biomarker and pharmacokinetic analysis of tumors from patients in the Mayo Phase II Consortium and the Cancer Therapeutics Research Group.PMC3438233N01CM62205N01-CM62205Lim RChan ATChan SLMa BBChan AWRha SYChung HCWang LZYeo WRoh JKYu SCErlichman CHui EPTo KFMo FKGoh BCJeung HCTong JHKoh JPicus JBoyer MTao QfalseEpigenetic therapy using belinostat for patients with unresectable hepatocellular carcinoma: a multicenter phase I/II study with biomarker and pharmacokinetic analysis of tumors from patients in the Mayo Phase II Consortium and the Cancer Therapeutics Research Group.<h4>Purpose</h4>Epigenetic aberrations have been reported in hepatocellular carcinoma (HCC). In this study of patients with unresectable HCC and chronic liver disease, epigenetic therapy with the histone deacetylase inhibitor belinostat was assessed. The objectives were to determine dose-limiting toxicity and maximum-tolerated dose (MTD), to assess pharmacokinetics in phase I, and to assess activity of and explore potential biomarkers for response in phase II.<h4>Patients and methods</h4>Major eligibility criteria included histologically confirmed unresectable HCC, European Cooperative Oncology Group performance score ≤ 2, and adequate organ function. Phase I consisted of 18 patients; belinostat was given intravenously once per day on days 1 to 5 every 3 weeks; dose levels were 600 mg/m(2)2012-01-01T00:00:00Z2012 Sep2025-04-19T15:58:39.503Z2019-03-27T00:57:46ZS-EPMC34382332291565810.1200/JCO.2011.41.239510.1200/jco.2011.41.2395