4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma
Shelter
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
1 other identifier
interventional
57
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hepatocellular-carcinoma
Started Jul 2009
Typical duration for phase_2 hepatocellular-carcinoma
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJanuary 16, 2014
January 1, 2014
2.9 years
July 21, 2009
January 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
4SC-201
EXPERIMENTAL4SC-201 + Sorafenib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 4SC AGlead
Study Sites (15)
ONKOPLUS Beratung und Hilfe für Menschen mit Krebs
Berlin, 14195, Germany
Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin)
Essen, 45147, Germany
Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I)
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)
Hamburg, 20246, Germany
Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)
Heidelberg, 69120, Germany
Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik)
Mainz, 55131, Germany
Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie)
Munich, 81675, Germany
Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I)
Tübingen, 72076, Germany
l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi
Bologna, 40138, Italy
l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)
Genova, 16132, Italy
Istituto Europea di Oncologia EIO
Milan, 20141, Italy
A.O.R.N. Monaldi-Cotugno-CTO
Napoli, 80131, Italy
l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV
Padua, Italy
l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"
Palermo, 12990127, Italy
L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.
Rozzano-Milano, 20089, Italy
Related Publications (1)
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.
PMID: 26952006DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bitzer, Prof. MD
Medizinische Universitäts-Klinik Tübingen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 22, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2012
Study Completion
September 1, 2013
Last Updated
January 16, 2014
Record last verified: 2014-01