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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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