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

January 15, 2014 updated by: 4SC AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14195
        • ONKOPLUS Beratung und Hilfe für Menschen mit Krebs
      • Essen, Germany, 45147
        • Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin)
      • Halle, Germany, 06120
        • Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I)
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)
      • Mainz, Germany, 55131
        • Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik)
      • Munich, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie)
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I)
  • Italy
      • Bologna, Italy, 40138
        • l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi
      • Genova, Italy, 16132
        • l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)
      • Milano, Italy, 20141
        • Istituto Europea di Oncologia EIO
      • Napoli, Italy, 80131
        • A.O.R.N. Monaldi-Cotugno-CTO
      • Padova, Italy
        • l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV
      • Palermo, Italy, 12990127
        • l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"
      • Rozzano-Milano, Italy, 20089
        • L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To establish the MTD of 4SC-201 in combination with Sorafenib
Time Frame: 12 weeks
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
Time Frame: 12 weeks
12 weeks
To investigate biomarkers
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

4SC AG

Investigators

  • Principal Investigator: Michael Bitzer, Prof. MD, Medizinische Universitäts-Klinik Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4SC-201-1-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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