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

Hepatocellular Carcinoma Clinical Trial

— Shelter  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943449
• Other study ID #: 4SC-201-1-2009
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2009
• Last updated: January 15, 2014
• Start date: July 2009
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: 4SC AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 4SC-201
oral administration
• Sorafenib
oral administration

Locations

Country	Name	City	State
Germany	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 Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)	Hamburg
Germany	Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)	Heidelberg
Germany	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
Italy	l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi	Bologna
Italy	l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)	Genova
Italy	Istituto Europea di Oncologia EIO	Milano
Italy	A.O.R.N. Monaldi-Cotugno-CTO	Napoli
Italy	l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV	Padova
Italy	l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"	Palermo
Italy	L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.	Rozzano-Milano

Sponsors (1)

Lead Sponsor	Collaborator
4SC AG

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival Rate (PFSR) of repeated oral doses of 4SC-201 and of the treatment combination of Sorafenib plus 4SC-201		12 weeks	No
Secondary	To establish the MTD of 4SC-201 in combination with Sorafenib		12 weeks	Yes
Secondary	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	Yes
Secondary	To investigate biomarkers		12 weeks	No