Centralized analysis of phase II ECG dataset of resminostat, an orally available histone-deacetylase inhibitor (HDACi).

e13526 Background: Resminostat (4SC-201) is an orally available pan-HDAC inhibitor that revealed substantial clinical activity and was well tolerated by patients with advanced malignancies when administered as single agent or in combination with anti-cancer compounds. Cardiac safety of resminostat was evaluated across patients of 3 clinical Phase II studies. Methods: Resminostat was administered in a dose range of 100 mg up to 800 mg once-daily in repeated 14-day cycles consisting of 5 consecutive treatment days followed by a 9-day rest period to 111 patients with advanced cancer (hepatocellular ca., Hodgkin lymphoma or colorectal ca.). Standard 12-lead rest ECGs were conducted frequently for determination of potential effects on QT interval prolongation. An intensive profile of >10 single ECGs was performed from Day 1 to 5 during Cycle 1, and less frequent in following cycles if no clinically relevant findings occurred. Subsequent to on-site clinical assessment, ECGs were analysed by a trained cardiologi...