André T Brunetto, Joo Ern Ang, Rohit Lal, David Olmos, L Rhoda Molife, Rebecca Kristeleit, Ann Parker, Isabel Casamayor, Muyibat Olaleye, Anna Mais, Bernhard Hauns, Vera Strobel, Bernd Hentsch, Johann S de Bono
PURPOSE: This first-in-human dose-escalating trial investigated the safety, tolerability, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), pharmacokinetics, and pharmacodynamics of the novel histone deacetylase (HDAC) inhibitor resminostat in patients with advanced solid tumors. EXPERIMENTAL DESIGN: Resminostat was administered orally once-daily on days 1 to 5 every 14 days at 5 dose levels between 100 and 800 mg. Safety, pharmacokinetics, pharmacodynamics including histone acetylation and HDAC enzyme activity, and antitumor efficacy were assessed...
October 1, 2013: Clinical Cancer Research