4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma

A Proof-of-concept Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of 4SC-201 and the Treatment Combination of Sorafenib Plus 4SC-201 in Patients With Hepatocellular Carcinoma Exhibiting Progressive Disease Under Sorafenib Treatment

The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.

Main Inclusion Criteria:

• Advanced stage hepatocellular carcinoma
• Patients exhibiting progressive disease under Sorafenib treatment
• Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included
• ECOG performance status 0, 1 or 2
• Precedent first-line treatment with Sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks

Main Exclusion Criteria:

• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) - any cancer curatively treated > 3 years prior to entry is permitted
• Renal failure requiring hemo- or peritoneal dialysis
• Known central nervous system (CNS) tumors including symptomatic brain metastasis
• Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I
• Pregnant or breastfeeding women
• Sorafenib intolerance
• Major surgery within the last 4 weeks