4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma
NCT ID: NCT00943449
Last Updated: 2014-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2009-07-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose Escalation of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
NCT00490685
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
NCT00105443
A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
NCT00492752
Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer
NCT01042041
Study of Sorafenib and Infusional 5-Fluorouracil in Advanced Hepatocellular Carcinoma (HCC)
NCT00619541
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
4SC-201
4SC-201
oral administration
4SC-201 + Sorafenib
4SC-201
oral administration
Sorafenib
oral administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
4SC-201
oral administration
Sorafenib
oral administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
4SC AG
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Bitzer, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Universitäts-Klinik Tübingen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ONKOPLUS Beratung und Hilfe für Menschen mit Krebs
Berlin, , Germany
Universitätsklinikum Essen (Innere Klinik/Tumorforschung und Zentrum für Innere Medizin)
Essen, , Germany
Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg (Klinik und Poliklinik für Innere Medizin I)
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf (I. Medizinische Klinik und Poliklinik)
Hamburg, , Germany
Universitätsklinikum Heidelberg (Medizinische Universitätsklinik/Innere Medizin IV/Nationales Centrum für Tumorerkrankungen)
Heidelberg, , Germany
Johannes Gutenberg-Universität Mainz (I. Medizinische Klinik und Poliklinik)
Mainz, , Germany
Klinikum rechts der Isar der Technischen Universität München (Medizinische Klinik und Poliklinik II/Gastroenterologie)
Munich, , Germany
Universitätsklinikum Tübingen (Medizinische Klinik/Innere Medizin I)
Tübingen, , Germany
l'Azienda Ospedaliero-Universitaria di Bologna-Policlinico S. Orsola Malpighi
Bologna, , Italy
l'Università degli Studi di Genova (Dipartimento di Medicina Interna e Specialità Mediche)
Genova, , Italy
Istituto Europea di Oncologia EIO
Milan, , Italy
A.O.R.N. Monaldi-Cotugno-CTO
Napoli, , Italy
l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV
Padua, , Italy
l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone"
Palermo, , Italy
L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A.
Rozzano-Milano, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4SC-201-1-2009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.