4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma (Shelter)
This study is ongoing, but not recruiting participants.
Sponsor:
4SC AG
Information provided by:
4SC AG
ClinicalTrials.gov Identifier:
NCT00943449
First received: July 21, 2009
Last updated: June 20, 2012
Last verified: June 2012
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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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated 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
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: | June 20, 2012 |
| 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013