Combination Treatment of Sorafenib and Resminostat, a new HDAC Inhibitor, in Patients with Sorafenib-resistant Hepatocellular Carcinoma (HCC) – Results of the Dose-Escalation Phase
M Bitzer, M Horger, TM Ganten, J Siveke, MA Woerns, M Dollinger, G Gerken, ME Scheulen, H Wege, A Mais, R Jankowsky, B Hauns, B Hentsch, UM Lauer · Zeitschrift für Gastroenterologie · 2012 · Heft 01
Bibliografische Angaben
Zusammenfassung
Aims: Resminostat (4SC–201), an orally taken pan-HDAC inhibitor, is currently under investigation in various oncological indications. The Phase I/II SHELTER study aims to evaluate safety, tolerability and efficacy in HCC patients (pts) exhibiting progressive disease under sorafenib (S) first-line therapy. Methods: Pts with advanced HCC (BCLC B, C) are included in a multi-center, open-label, two-arm parallel group trial. Progression under S is confirmed by central review prior to study entry. Arm B investigates resminostat monotherapy, Arm A a combination with S to overcome treatment resistance, including a dose…
