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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2018
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Germany,  Ireland,  Italy,  Netherlands,  Poland,  Sweden,  United Kingdom, 

Outcome

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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