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
| Registry | NCT00943449, acronym Shelter |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 57 (Actual) |
| Sponsor | 4SC AG (Industry) |
| Conditions | Hepatocellular Carcinoma |
| Interventions | 4SC-201, Sorafenib (Drug) |
| Dates | start 2009-07-01, primary completion 2012-06-01, completion 2013-09-01, first posted 2009-07-22, last updated 2014-01-16 |
| Locations | 15 sites in Germany, Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Hepatocellular Carcinoma All trials of 4SC-201 All trials of Sorafenib
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 4SC-201 | Experimental | Drug: 4SC-201 | |
| 4SC-201 + Sorafenib | Experimental | Drug: 4SC-201; Drug: Sorafenib |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 | Naples | Italy | |
| l'Azienda Ospedaliera di Padova and l'Istituto Oncologico Veneto IOV | Padova | Italy | |
| l'Ente "Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone" | Palermo | Italy | |
| L'Istituto Clinico Humanitas-Humanitas Mirasole S.p.A. | Rozzano-Milano | Italy |