An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)
- Conditions
- Malignant Melanoma
- Registration Number
- NCT01990248
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 339
- Adult patients of the age of 18 years or older
- Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
- Vemurafenib treatment must have been initiated at the time of enrollment or no more than one month prior to enrollment
- Patient (or legally acceptable representative) has personally signed and dated the informed consent document indicating that he or she has been informed of all pertinent aspects of the study, if applicable
- Patient is willing to provide information on at least one alternate contact person for study staff to contact regarding the patient's whereabouts, should the patient become lost to follow-up during the course of the study
- Patient was treated with vemurafenib as part of a clinical trial or expanded access program
- Patient has participated in any studies involving any investigational study drug within one month prior to initiating vemurafenib treatment
- Patient has any significant history of disease of medical condition (except metastatic melanoma) which in the judgment of the investigator has the potential to impact participation on the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of non-cutaneous squamous cell carcinoma 2 years Incidence of cutaneous squamous cell carcinoma 2 years Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms) 2 years Incidence of abnormal liver function 2 years
- Secondary Outcome Measures
Name Time Method Incidence of a second (or subsequent) primary melanoma 2 years Incidence of gastrointestinal polyps 2 years Incidence of adverse events 2 years
Trial Locations
- Locations (80)
LKH Feldkirch; Onkologie
🇦🇹Feldkirch, Austria
Ordensklinikum Linz Elisabethinen ; Dermatologie
🇦🇹Linz, Austria
Krankenhaus Hietzing Wien
🇦🇹Wien, Austria
ZNA Middelheim
🇧🇪Antwerpen, Belgium
CHIREC Edith Cavell
🇧🇪Bruxelles, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
Galway University Hospital; Clinical Trials Department
🇮🇪Galway, Ireland
Amphia Ziekenhuis, locatie Langendijk;Oncology
🇳🇱Breda, Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
🇳🇱Groningen, Netherlands
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
🇵🇱Bydgoszcz, Poland
RegioNAlny Osrodek Onkologiczny Pododdział Diagnostyki i Terapii Onkologicznej
🇵🇱Lodz, Poland
Regionalny Osrodek Onkologiczny; Oddzial Chorob Rozrostowych
🇵🇱Lodz, Poland
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller
🇩🇪Leer, Germany
Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie
🇩🇪Muenster, Germany
UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d
🇩🇪Lübeck, Germany
Klinikum Vest; Behandlungszentrum Kanppschaftskrankenhaus Recklinghausen
🇩🇪Recklinghausen, Germany
Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia
🇮🇹Modena, Emilia-Romagna, Italy
A.U Careggi di Firenze;Oncologia
🇮🇹Firenze, Toscana, Italy
A.O.V.V. - P.O. di Sondrio; S.O.C. Oncologia Medica
🇮🇹Sondrio, Lombardia, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
🇮🇹Siena, Toscana, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej; Opolskie Centrum Onkologii
🇵🇱Opole, Poland
St James University Hospital
🇬🇧Leeds, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
🇬🇧London, United Kingdom
Addenbrookes Hospital; Dept of Oncology
🇬🇧Cambridge, United Kingdom
Cheltenham General Hospital; Gloucestershire Oncology Centre
🇬🇧Cheltenham, United Kingdom
St Helens & Knowsley Trust
🇬🇧St Helens, United Kingdom
New Cross Hospital; Deansley Centre
🇬🇧Wolverhampton, United Kingdom
Ospedale "Guglielmo da Saliceto";U.O. Medicina Oncologica
🇮🇹Piacenza, Emilia-Romagna, Italy
Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten
🇩🇪Greifswald, Germany
Charite- universitatsmedizin Berlin; Med. Klinik mit Schwerpunkt Hamatologie und Onkologie
🇩🇪Berlin, Germany
Dermatologisches Zentrum am Elbe Klinikum Buxtehude
🇩🇪Buxtehude, Germany
FN Ostrava; Dermatology dep
🇨🇿Ostrava, Czechia
Universitatsklinikum Bonn; Klinisches Studienzentrum Klinik fur Dermatologie
🇩🇪Bonn, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Hauttumorzentrum Rheinpfalz
🇩🇪Ludwigshafen, Germany
University Hospital Prague
🇨🇿Praha, Czechia
Universitaetsmedizin Goettingen; Abteilung Dermato-Onkologie
🇩🇪Göttingen, Germany
Univ.- Hautklinik Heidelberg
🇩🇪Heidelberg, Germany
Friedrich-Schiller-Universitaet Jena; Klinik fuer Dermatologie und dermatologische Allergologie
🇩🇪Jena, Germany
Johannes Wesling Klinikum Minden;Haut Tumor Centrum Minden
🇩🇪Minden, Germany
Dermatologie und Allergologie HELIOS Hauttumorzentrum Erfurt
🇩🇪Erfurt, Germany
Universitatsklinikum Essen; Klinik für Dermatologie
🇩🇪Essen, Germany
Ruhr-Universität Bochum; Klinik für Dermatologie und Allergologie
🇩🇪Bochum, Germany
DRK Krankenhaus Chemnitz-Rabenstein; Hautkrebszentrum Chemnitz
🇩🇪Chemnitz, Germany
Klinikum Augsburg; Hauttumorzentrum
🇩🇪Augsburg, Germany
Universitätsklinikum Düsseldorf; Hautklinik
🇩🇪Düsseldorf, Germany
SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
🇩🇪Gera, Germany
Medizinisches Zentrum
🇩🇪Bonn, Germany
Komplexni onkologicke centrum Krajske nemocnice T. Bati, a.s. Zlin
🇨🇿Zlin, Czechia
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie
🇩🇪Dresden, Germany
Klinikum Kassel GmbH; Hauttumorzentrum HTZ
🇩🇪Kassel, Germany
Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz
🇩🇪Mainz, Germany
Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica
🇮🇹Faenza, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Lombardia, Italy
Fachklinik Hornheide; Abteilung für Dermatologie
🇩🇪Muenster, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz
🇩🇪Quedlinburg, Germany
Istituto Nazionale Tumori Fondazione G. Pascale
🇮🇹Napoli, Campania, Italy
Eberhard-Karls-Universitat Tubingen; Sektion Dermatologische Onkologie
🇩🇪Tuebingen, Germany
Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
🇩🇪Nürnberg, Germany
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
🇮🇹Milano, Lombardia, Italy
Policlinico S. Orsola Malpighi;Dip. Ematologia, Oncologia e Medicina di Laboratorio
🇮🇹Bologna, Emilia-Romagna, Italy
Azienda ASL di Rimini (Presidi di Rimini - Cattolica)) - Ospedale degli Infermi;U.O. Oncologia
🇮🇹Rimini, Emilia-Romagna, Italy
Fondazione IRCCS Policlinico San Matteo, Oncologia
🇮🇹Pavia, Lombardia, Italy
Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
🇩🇪Würzburg, Germany
Atrium MC, Parkstad Heerlen; Poli Interne
🇳🇱Heerlen, Netherlands
Maastricht University Medical Center,Division of Medical Oncology; Dept. Internal Medicine
🇳🇱Maastricht, Netherlands
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
🇵🇱Krakow, Poland
Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
🇵🇱Warszawa, Poland
Blekingesjukhuset; Kirurgkliniken
🇸🇪Karlskrona, Sweden
Karolinska University Hospital;Department of Oncology-Pathology
🇸🇪Stockholm, Sweden
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Velindre Cancer Centre
🇬🇧Cardiff, United Kingdom
Dorset County Hospital NHS Foundation Trust;Research and Development/ Oncology
🇬🇧Dorchester, United Kingdom
Imperial College Healthcare NHS Trust;Medical Oncology
🇬🇧London, United Kingdom
The Clatterbridge Cancer Ctr For Oncolgy
🇬🇧Wirral, United Kingdom
St George's Hospital; Oncology
🇬🇧London, United Kingdom
Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie
🇩🇪Mannheim, Germany
Universitätsmedizin Rostock; Klinik und Poliklinik für Dermatologie und Venerologie
🇩🇪Rostock, Germany