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

4SC

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Sorafenib

Drug: 4SC-201

Study type

Interventional

Funder types

Industry

Identifiers

NCT00943449

4SC-201-1-2009

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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