First clinical data of resminostat, a novel oral histone deacetylase (HDAC) inhibitor, in patients with hepatocellular carcinoma (HCC) – the SHELTER Study

Aims: Resminostat (4SC-201) is a novel specific pan-HDAC inhibitor under clinical evaluation as mono or combination therapy for solid and hematological malignancies. Here, we describe the first results of a phase II study being started in 2009 to evaluate the safety, tolerability and efficacy of resminostat in patients with HCC exhibiting progressive disease under sorafenib first-line therapy. Methods: Patients with advanced stage HCC, BCLC classes B or C are included in a multi-center, open-label, two-arm parallel group trial. Arm A consists of a combination treatment of resminostat and sorafenib with escalatin…