Malignant Melanoma Clinical Trial
Official title:
ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)
| NCT number | NCT01990248 |
| Other study ID # | GP28492 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 23, 2013 |
| Est. completion date | July 26, 2016 |
| Verified date | June 2018 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 339 |
| Est. completion date | July 26, 2016 |
| Est. primary completion date | July 26, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | LKH Feldkirch; Onkologie | Feldkirch | |
| Austria | Ordensklinikum Linz Elisabethinen ; Dermatologie | Linz | |
| Austria | Krankenhaus Hietzing Wien | Wien | |
| Belgium | ZNA Middelheim | Antwerpen | |
| Belgium | CHIREC Edith Cavell | Bruxelles | |
| Belgium | Cliniques Universitaires St-Luc | Bruxelles | |
| Belgium | UZ Antwerpen | Edegem | |
| Czechia | FN Ostrava; Dermatology dep | Ostrava | |
| Czechia | University Hospital Prague | Praha | |
| Czechia | Komplexni onkologicke centrum Krajske nemocnice T. Bati, a.s. Zlin | Zlin | |
| Germany | Klinikum Augsburg; Hauttumorzentrum | Augsburg | |
| Germany | Charite- universitatsmedizin Berlin; Med. Klinik mit Schwerpunkt Hamatologie und Onkologie | Berlin | |
| Germany | Ruhr-Universität Bochum; Klinik für Dermatologie und Allergologie | Bochum | |
| Germany | Medizinisches Zentrum | Bonn | |
| Germany | Universitatsklinikum Bonn; Klinisches Studienzentrum Klinik fur Dermatologie | Bonn | |
| Germany | Dermatologisches Zentrum am Elbe Klinikum Buxtehude | Buxtehude | |
| Germany | DRK Krankenhaus Chemnitz-Rabenstein; Hautkrebszentrum Chemnitz | Chemnitz | |
| Germany | Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie | Dresden | |
| Germany | Universitätsklinikum Düsseldorf; Hautklinik | Düsseldorf | |
| Germany | Dermatologie und Allergologie HELIOS Hauttumorzentrum Erfurt | Erfurt | |
| Germany | Universitatsklinikum Essen; Klinik für Dermatologie | Essen | |
| Germany | SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS) | Gera | |
| Germany | Universitaetsmedizin Goettingen; Abteilung Dermato-Onkologie | Göttingen | |
| Germany | Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten | Greifswald | |
| Germany | Univ.- Hautklinik Heidelberg | Heidelberg | |
| Germany | Friedrich-Schiller-Universitaet Jena; Klinik fuer Dermatologie und dermatologische Allergologie | Jena | |
| Germany | Klinikum Kassel GmbH; Hauttumorzentrum HTZ | Kassel | |
| Germany | Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller | Leer | |
| Germany | UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d | Lübeck | |
| Germany | Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Hauttumorzentrum Rheinpfalz | Ludwigshafen | |
| Germany | Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz | Mainz | |
| Germany | Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie | Mannheim | |
| Germany | Johannes Wesling Klinikum Minden;Haut Tumor Centrum Minden | Minden | |
| Germany | Fachklinik Hornheide; Abteilung für Dermatologie | Muenster | |
| Germany | Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie | Muenster | |
| Germany | Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie | Nürnberg | |
| Germany | Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz | Quedlinburg | |
| Germany | Klinikum Vest; Behandlungszentrum Kanppschaftskrankenhaus Recklinghausen | Recklinghausen | |
| Germany | Universitätsmedizin Rostock; Klinik und Poliklinik für Dermatologie und Venerologie | Rostock | |
| Germany | Eberhard-Karls-Universitat Tubingen; Sektion Dermatologische Onkologie | Tuebingen | |
| Germany | Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie | Würzburg | |
| Ireland | Galway University Hospital; Clinical Trials Department | Galway | |
| Italy | Policlinico S. Orsola Malpighi;Dip. Ematologia, Oncologia e Medicina di Laboratorio | Bologna | Emilia-Romagna |
| Italy | Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica | Faenza | Emilia-Romagna |
| Italy | A.U Careggi di Firenze;Oncologia | Firenze | Toscana |
| Italy | Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milano | Lombardia |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | Lombardia |
| Italy | Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia | Modena | Emilia-Romagna |
| Italy | Istituto Nazionale Tumori Fondazione G. Pascale | Napoli | Campania |
| Italy | Fondazione IRCCS Policlinico San Matteo, Oncologia | Pavia | Lombardia |
| Italy | Ospedale "Guglielmo da Saliceto";U.O. Medicina Oncologica | Piacenza | Emilia-Romagna |
| Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | Toscana |
| Italy | Azienda ASL di Rimini (Presidi di Rimini - Cattolica)) - Ospedale degli Infermi;U.O. Oncologia | Rimini | Emilia-Romagna |
| Italy | Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica | Siena | Toscana |
| Italy | A.O.V.V. - P.O. di Sondrio; S.O.C. Oncologia Medica | Sondrio | Lombardia |
| Netherlands | Amphia Ziekenhuis, locatie Langendijk;Oncology | Breda | |
| Netherlands | Academ Ziekenhuis Groningen; Medical Oncology | Groningen | |
| Netherlands | Atrium MC, Parkstad Heerlen; Poli Interne | Heerlen | |
| Netherlands | Maastricht University Medical Center,Division of Medical Oncology; Dept. Internal Medicine | Maastricht | |
| Poland | Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii | Bydgoszcz | |
| Poland | Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Onkologii | Krakow | |
| Poland | RegioNAlny Osrodek Onkologiczny Pododdzial Diagnostyki i Terapii Onkologicznej | Lodz | |
| Poland | Regionalny Osrodek Onkologiczny; Oddzial Chorob Rozrostowych | Lodz | |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej; Opolskie Centrum Onkologii | Opole | |
| Poland | Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow | Warszawa | |
| Sweden | Blekingesjukhuset; Kirurgkliniken | Karlskrona | |
| Sweden | Karolinska University Hospital;Department of Oncology-Pathology | Stockholm | |
| United Kingdom | Royal Sussex County Hospital | Brighton | |
| United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
| United Kingdom | Addenbrookes Hospital; Dept of Oncology | Cambridge | |
| United Kingdom | Velindre Cancer Centre | Cardiff | |
| United Kingdom | Cheltenham General Hospital; Gloucestershire Oncology Centre | Cheltenham | |
| United Kingdom | Dorset County Hospital NHS Foundation Trust;Research and Development/ Oncology | Dorchester | |
| United Kingdom | St James University Hospital | Leeds | |
| United Kingdom | Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | |
| United Kingdom | Imperial College Healthcare NHS Trust;Medical Oncology | London | |
| United Kingdom | St George's Hospital; Oncology | London | |
| United Kingdom | St Helens & Knowsley Trust | St Helens | |
| United Kingdom | The Clatterbridge Cancer Ctr For Oncolgy | Wirral | |
| United Kingdom | New Cross Hospital; Deansley Centre | Wolverhampton |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Austria, Belgium, Czechia, Germany, Ireland, Italy, Netherlands, Poland, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of non-cutaneous squamous cell carcinoma | 2 years | ||
| Primary | Incidence of cutaneous squamous cell carcinoma | 2 years | ||
| Primary | Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms) | 2 years | ||
| Primary | Incidence of abnormal liver function | 2 years | ||
| Secondary | Incidence of a second (or subsequent) primary melanoma | 2 years | ||
| Secondary | Incidence of gastrointestinal polyps | 2 years | ||
| Secondary | Incidence of adverse events | 2 years |
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