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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
4SC-201
Sorafenib
Sponsored by
4SC AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Sorafenib, HDAC, 4SC-201, Phase II, Resminostat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

4SC-201

4SC-201 + Sorafenib

Arm Description

Outcomes

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

Secondary Outcome Measures

To establish the MTD of 4SC-201 in combination with Sorafenib
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
To investigate biomarkers

Full Information

First Posted
July 21, 2009
Last Updated
January 15, 2014
Sponsor
4SC AG
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1. Study Identification

Unique Protocol Identification Number
NCT00943449
Brief Title
4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
4SC AG

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Sorafenib, HDAC, 4SC-201, Phase II, Resminostat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4SC-201
Arm Type
Experimental
Arm Title
4SC-201 + Sorafenib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
4SC-201
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To establish the MTD of 4SC-201 in combination with Sorafenib
Time Frame
12 weeks
Title
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
Title
To investigate biomarkers
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bitzer, Prof. MD
Organizational Affiliation
Medizinische Universitäts-Klinik Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
ONKOPLUS Beratung und Hilfe für Menschen mit Krebs
City
Berlin
ZIP/Postal Code
14195
Country
Germany
Facility Name
Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin)
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik)
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie)
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I)
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Europea di Oncologia EIO
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
A.O.R.N. Monaldi-Cotugno-CTO
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV
City
Padova
Country
Italy
Facility Name
l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"
City
Palermo
ZIP/Postal Code
12990127
Country
Italy
Facility Name
L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.
City
Rozzano-Milano
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26952006
Citation
Bitzer M, Horger M, Giannini EG, Ganten TM, Worns MA, Siveke JT, Dollinger MM, Gerken G, Scheulen ME, Wege H, Zagonel V, Cillo U, Trevisani F, Santoro A, Montesarchio V, Malek NP, Holzapfel J, Herz T, Ammendola AS, Pegoraro S, Hauns B, Mais A, Lauer UM, Henning SW, Hentsch B. Resminostat plus sorafenib as second-line therapy of advanced hepatocellular carcinoma - The SHELTER study. J Hepatol. 2016 Aug;65(2):280-8. doi: 10.1016/j.jhep.2016.02.043. Epub 2016 Mar 4.
Results Reference
derived

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

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