Status:
COMPLETED
4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma
Lead Sponsor:
4SC AG
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 m...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00943449
Start Date
July 1 2009
End Date
September 1 2013
Last Update
January 16 2014
Active Locations (15)
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1
ONKOPLUS Beratung und Hilfe für Menschen mit Krebs
Berlin, Germany, 14195
2
Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin)
Essen, Germany, 45147
3
Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I)
Halle, Germany, 06120
4
Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)
Hamburg, Germany, 20246