Clincosm LogoSign in Get a demo

An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01990248
Collaborator
(none)
339
Enrollment
80
Locations
40.1
Actual Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    339 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)
    Actual Study Start Date :
    Mar 23, 2013
    Actual Primary Completion Date :
    Jul 26, 2016
    Actual Study Completion Date :
    Jul 26, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of non-cutaneous squamous cell carcinoma [2 years]

    2. Incidence of cutaneous squamous cell carcinoma [2 years]

    3. Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms) [2 years]

    4. Incidence of abnormal liver function [2 years]

    Secondary Outcome Measures

    1. Incidence of a second (or subsequent) primary melanoma [2 years]

    2. Incidence of gastrointestinal polyps [2 years]

    3. Incidence of adverse events [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LKH Feldkirch; Onkologie Feldkirch Austria 6800
    2 Ordensklinikum Linz Elisabethinen ; Dermatologie Linz Austria 4020
    3 Krankenhaus Hietzing Wien Wien Austria 1130
    4 ZNA Middelheim Antwerpen Belgium 2020
    5 CHIREC Edith Cavell Bruxelles Belgium 1180
    6 Cliniques Universitaires St-Luc Bruxelles Belgium 1200
    7 UZ Antwerpen Edegem Belgium 2650
    8 FN Ostrava; Dermatology dep Ostrava Czechia 708 52
    9 University Hospital Prague Praha Czechia 150 06
    10 Komplexni onkologicke centrum Krajske nemocnice T. Bati, a.s. Zlin Zlin Czechia 760 01
    11 Klinikum Augsburg; Hauttumorzentrum Augsburg Germany 86179
    12 Charite- universitatsmedizin Berlin; Med. Klinik mit Schwerpunkt Hamatologie und Onkologie Berlin Germany 12200
    13 Ruhr-Universität Bochum; Klinik für Dermatologie und Allergologie Bochum Germany 44791
    14 Universitatsklinikum Bonn; Klinisches Studienzentrum Klinik fur Dermatologie Bonn Germany 53105
    15 Medizinisches Zentrum Bonn Germany 53111
    16 Dermatologisches Zentrum am Elbe Klinikum Buxtehude Buxtehude Germany 21614
    17 DRK Krankenhaus Chemnitz-Rabenstein; Hautkrebszentrum Chemnitz Chemnitz Germany 09117
    18 Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie Dresden Germany 01307
    19 Universitätsklinikum Düsseldorf; Hautklinik Düsseldorf Germany 40225
    20 Dermatologie und Allergologie HELIOS Hauttumorzentrum Erfurt Erfurt Germany 99089
    21 Universitatsklinikum Essen; Klinik für Dermatologie Essen Germany 45147
    22 SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS) Gera Germany 07548
    23 Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten Greifswald Germany 17487
    24 Universitaetsmedizin Goettingen; Abteilung Dermato-Onkologie Göttingen Germany 37075
    25 Univ.- Hautklinik Heidelberg Heidelberg Germany 69115
    26 Friedrich-Schiller-Universitaet Jena; Klinik fuer Dermatologie und dermatologische Allergologie Jena Germany 07743
    27 Klinikum Kassel GmbH; Hauttumorzentrum HTZ Kassel Germany 34125
    28 Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller Leer Germany 26789
    29 Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Hauttumorzentrum Rheinpfalz Ludwigshafen Germany 67063
    30 UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d Lübeck Germany 23538
    31 Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz Mainz Germany 55131
    32 Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie Mannheim Germany 68167
    33 Johannes Wesling Klinikum Minden;Haut Tumor Centrum Minden Minden Germany 32429
    34 Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie Muenster Germany 48149
    35 Fachklinik Hornheide; Abteilung für Dermatologie Muenster Germany 48157
    36 Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie Nürnberg Germany 90419
    37 Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz Quedlinburg Germany 06484
    38 Klinikum Vest; Behandlungszentrum Kanppschaftskrankenhaus Recklinghausen Recklinghausen Germany 45657
    39 Universitätsmedizin Rostock; Klinik und Poliklinik für Dermatologie und Venerologie Rostock Germany 18057
    40 Eberhard-Karls-Universitat Tubingen; Sektion Dermatologische Onkologie Tuebingen Germany 72076
    41 Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie Würzburg Germany 97080
    42 Galway University Hospital; Clinical Trials Department Galway Ireland
    43 Istituto Nazionale Tumori Fondazione G. Pascale Napoli Campania Italy 80131
    44 Policlinico S. Orsola Malpighi;Dip. Ematologia, Oncologia e Medicina di Laboratorio Bologna Emilia-Romagna Italy 40138
    45 Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica Faenza Emilia-Romagna Italy 48018
    46 Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia Modena Emilia-Romagna Italy 41100
    47 Ospedale "Guglielmo da Saliceto";U.O. Medicina Oncologica Piacenza Emilia-Romagna Italy 29121
    48 Azienda ASL di Rimini (Presidi di Rimini - Cattolica)) - Ospedale degli Infermi;U.O. Oncologia Rimini Emilia-Romagna Italy 47922
    49 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Lombardia Italy 20133
    50 Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia Milano Lombardia Italy 20162
    51 Fondazione IRCCS Policlinico San Matteo, Oncologia Pavia Lombardia Italy 27100
    52 A.O.V.V. - P.O. di Sondrio; S.O.C. Oncologia Medica Sondrio Lombardia Italy 23100
    53 A.U Careggi di Firenze;Oncologia Firenze Toscana Italy 50134
    54 Azienda Ospedaliero Universitaria Pisana Pisa Toscana Italy 56100
    55 Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica Siena Toscana Italy 53100
    56 Amphia Ziekenhuis, locatie Langendijk;Oncology Breda Netherlands 4819 EV
    57 Academ Ziekenhuis Groningen; Medical Oncology Groningen Netherlands 9713 GZ
    58 Atrium MC, Parkstad Heerlen; Poli Interne Heerlen Netherlands 6419 PC
    59 Maastricht University Medical Center,Division of Medical Oncology; Dept. Internal Medicine Maastricht Netherlands 6229 HX
    60 Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii Bydgoszcz Poland 85-796
    61 Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii Krakow Poland 31-531
    62 RegioNAlny Osrodek Onkologiczny Pododdział Diagnostyki i Terapii Onkologicznej Lodz Poland 93-513
    63 Regionalny Osrodek Onkologiczny; Oddzial Chorob Rozrostowych Lodz Poland 93-513
    64 Samodzielny Publiczny Zaklad Opieki Zdrowotnej; Opolskie Centrum Onkologii Opole Poland 45-060
    65 Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow Warszawa Poland 02-781
    66 Blekingesjukhuset; Kirurgkliniken Karlskrona Sweden 371 85
    67 Karolinska University Hospital;Department of Oncology-Pathology Stockholm Sweden 17176
    68 Royal Sussex County Hospital Brighton United Kingdom BN2 5BE
    69 Bristol Haematology and Oncology Centre Bristol United Kingdom BS2 8ED
    70 Addenbrookes Hospital; Dept of Oncology Cambridge United Kingdom CB2 2QQ
    71 Velindre Cancer Centre Cardiff United Kingdom CF14 2TL
    72 Cheltenham General Hospital; Gloucestershire Oncology Centre Cheltenham United Kingdom GL53 7AN
    73 Dorset County Hospital NHS Foundation Trust;Research and Development/ Oncology Dorchester United Kingdom DT1 2JY
    74 St James University Hospital Leeds United Kingdom LS9 7TF
    75 Guys and St Thomas NHS Foundation Trust, Guys Hospital London United Kingdom SE1 9RT
    76 St George's Hospital; Oncology London United Kingdom SW17 0QT
    77 Imperial College Healthcare NHS Trust;Medical Oncology London United Kingdom W6 8RF
    78 St Helens & Knowsley Trust St Helens United Kingdom WA9 3DA
    79 The Clatterbridge Cancer Ctr For Oncolgy Wirral United Kingdom CH63 4JY
    80 New Cross Hospital; Deansley Centre Wolverhampton United Kingdom WV10 0QP

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT01990248
    Other Study ID Numbers:
    • GP28492
    First Posted:
    Nov 21, 2013
    Last Update Posted:
    Jun 19, 2018
    Last Verified:
    Jun 1, 2018
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Jun 19, 2018