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

This study has been completed.
Sponsor:
Information provided by:
4SC AG
ClinicalTrials.gov Identifier:
NCT00943449
First received: July 21, 2009
Last updated: January 15, 2014
Last verified: January 2014
  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 2

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:


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 ]

Enrollment: 57
Study Start Date: July 2009
Study Completion Date: September 2013
Primary Completion Date: June 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
ONKOPLUS Beratung und Hilfe für Menschen mit Krebs
Berlin, Germany, 14195
Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin)
Essen, Germany, 45147
Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I)
Halle, Germany, 06120
Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)
Hamburg, Germany, 20246
Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)
Heidelberg, Germany, 69120
Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik)
Mainz, Germany, 55131
Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie)
Munich, Germany, 81675
Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I)
Tübingen, Germany, 72076
Italy
l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)
Genova, Italy, 16132
Istituto Europea di Oncologia EIO
Milano, Italy, 20141
A.O.R.N. Monaldi-Cotugno-CTO
Napoli, Italy, 80131
l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV
Padova, Italy
l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"
Palermo, Italy, 12990127
L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.
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: January 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 4SC AG:
Hepatocellular Carcinoma
Sorafenib
HDAC
4SC-201
Phase II
Resminostat

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014