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

Sponsor

4SC AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00943449

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: 4SC-201 Drug: Sorafenib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 4SC-201	Drug: 4SC-201 oral administration
Experimental: 4SC-201 + Sorafenib	Drug: 4SC-201 oral administration Drug: Sorafenib oral administration

Arm

Intervention/Treatment

Experimental: 4SC-201

Drug: 4SC-201

oral administration

Experimental: 4SC-201 + Sorafenib

Drug: 4SC-201

oral administration

Drug: Sorafenib

oral administration

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)	Heidelberg	Germany	69120
6	Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik)	Mainz	Germany	55131
7	Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie)	Munich	Germany	81675
8	Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I)	Tübingen	Germany	72076
9	l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi	Bologna	Italy	40138
10	l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)	Genova	Italy	16132
11	Istituto Europea di Oncologia EIO	Milano	Italy	20141
12	A.O.R.N. Monaldi-Cotugno-CTO	Napoli	Italy	80131
13	l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV	Padova	Italy
14	l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"	Palermo	Italy	12990127
15	L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.	Rozzano-Milano	Italy	20089