4SC-201 and Sorafenib in Advanced Hepatocellular Carcinoma - Full Text View

Sponsor:	4SC AG
Information provided by:	4SC AG
ClinicalTrials.gov Identifier:	NCT00943449

Purpose

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	Intervention	Phase
Hepatocellular Carcinoma	Drug: 4SC-201 Drug: Sorafenib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by 4SC AG:

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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To establish the MTD of 4SC-201 in combination with Sorafenib [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To investigate biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	July 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 4SC-201	Drug: 4SC-201 oral administration
Experimental: 4SC-201 + Sorafenib	Drug: 4SC-201 oral administration Drug: Sorafenib oral administration

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943449

Contacts

Contact: Bernhard Hauns, MD

+49-89-700763-0

Bernhard.Hauns@4sc.com

Locations

Germany
ONKOPLUS Beratung und Hilfe für Menschen mit Krebs	Active, not recruiting
Berlin, Germany, 14195
Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin)	Recruiting
Essen, Germany, 45147
Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I)	Recruiting
Halle, Germany, 06120
Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)	Recruiting
Hamburg, Germany, 20246
Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)	Recruiting
Heidelberg, Germany, 69120
Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik)	Recruiting
Mainz, Germany, 55131
Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie)	Recruiting
Munich, Germany, 81675
Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I)	Recruiting
Tübingen, Germany, 72076
Italy
l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi	Recruiting
Bologna, Italy, 40138
l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)	Recruiting
Genova, Italy, 16132
Istituto Europea di Oncologia EIO	Recruiting
Milano, Italy, 20141
A.O.R.N. Monaldi-Cotugno-CTO	Recruiting
Napoli, Italy, 80131
l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV	Recruiting
Padova, Italy
l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"	Recruiting
Palermo, Italy, 12990127
L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.	Recruiting
Rozzano-Milano, Italy, 20089

Sponsors and Collaborators

4SC AG

Investigators

Principal Investigator:

Michael Bitzer, Prof. MD

Medizinische Universitäts-Klinik Tübingen

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00943449 History of Changes
Other Study ID Numbers:	4SC-201-1-2009
Study First Received:	July 21, 2009
Last Updated:	October 17, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 4SC AG:

Hepatocellular Carcinoma
Sorafenib
HDAC
4SC-201
Phase II

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012