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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 4SC AG
• Treatments: Niacinamide; Sorafenib

Criteria

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