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

June 18, 2018 updated by: Hoffmann-La Roche

ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

339

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with unresectable or metastatic melanoma treated with vemurafenib

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of non-cutaneous squamous cell carcinoma
Time Frame: 2 years
2 years
Incidence of cutaneous squamous cell carcinoma
Time Frame: 2 years
2 years
Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms)
Time Frame: 2 years
2 years
Incidence of abnormal liver function
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: 2 years
2 years
Incidence of a second (or subsequent) primary melanoma
Time Frame: 2 years
2 years
Incidence of gastrointestinal polyps
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2013

Primary Completion (Actual)

July 26, 2016

Study Completion (Actual)

July 26, 2016

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP28492

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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