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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: 4SC-201; Drug: Sorafenib

• Registration Number: NCT00943449
• Lead Sponsor: 4SC AG

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 monotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Primary Completion: 2012-06
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4SC-201	4SC-201	-
4SC-201 + Sorafenib	4SC-201	-
4SC-201 + Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival Rate (PFSR) of repeated oral doses of 4SC-201 and of the treatment combination of Sorafenib plus 4SC-201	12 weeks

Secondary Outcome Measures

Name	Time	Method
To establish the MTD of 4SC-201 in combination with Sorafenib	12 weeks
To investigate the safety and tolerability of repeated oral doses of 4SC-201 and of the treatment combination of ascending repeated oral doses of 4SC-201 and Sorafenib	12 weeks
To investigate biomarkers	12 weeks

Trial Locations

Locations (15)

l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi; 🇮🇹 Bologna, Italy

Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik); 🇩🇪 Hamburg, Germany

Istituto Europea di Oncologia EIO; 🇮🇹 Milano, Italy

A.O.R.N. Monaldi-Cotugno-CTO; 🇮🇹 Napoli, Italy

ONKOPLUS Beratung und Hilfe für Menschen mit Krebs; 🇩🇪 Berlin, Germany

Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin); 🇩🇪 Essen, Germany

Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I); 🇩🇪 Halle, Germany

Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen); 🇩🇪 Heidelberg, Germany

l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche); 🇮🇹 Genova, Italy

Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik); 🇩🇪 Mainz, Germany

Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie); 🇩🇪 Munich, Germany

Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I); 🇩🇪 Tübingen, Germany

l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"; 🇮🇹 Palermo, Italy

l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV; 🇮🇹 Padova, Italy

L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.; 🇮🇹 Rozzano-Milano, Italy