A Study of Vemurafenib in Participants With Metastatic Melanoma

NCT ID: NCT01307397

Last Updated: 2017-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-01
• Study Completion Date: 2016-02-24

Brief Summary

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vemurafenib

Participants will receive vemurafenib at a dose of 960 milligrams (mg) twice daily (bid) until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.

Group Type: EXPERIMENTAL

Vemurafenib

Intervention Type: DRUG

Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.

Interventions

Vemurafenib

Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.

Intervention Type: DRUG

Other Intervention Names

RO5185426, Zelboraf

Eligibility Criteria

Inclusion Criteria

• Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
• Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
• Participants may or may not have received prior systemic therapy for metastatic melanoma
• Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
• Adequate hematologic, renal and liver function

Exclusion Criteria

• Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
• Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
• Concurrent administration of any anti-cancer therapies other than those administered in the study
• Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
• Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University "Mother Theresa" Hospital Center; Oncology Department

Tirana, , Albania

Hospital Britanico; Oncologia

Buenos Aires, , Argentina

Fundación CIDEA

Buenos Aires, , Argentina

Inst. Alexander Fleming; Oncologia

Buenos Aires, , Argentina

Melanoma Institute Australia

North Sydney, New South Wales, Australia

Newcastle Mater Misericordiae Hospital; Oncology

Waratah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Border Medical Oncology

Wodonga, New South Wales, Australia

Greenslopes Private Hospital; Gallipoli Research Centre

Greenslopes, Queensland, Australia

The Townsville Hospital; Townsville Cancer Centre

Townsville, Queensland, Australia

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital; Oncology

Adelaide, South Australia, Australia

Geelong Hospital; Geelong Cardiology Practice

Geelong, Victoria, Australia

Peter MacCallum Cancer Centre; Medical Oncology

Melbourne, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Landeskrankenhaus Feldkirch; Abteilung für Innere Medizin

Feldkirch, , Austria

LKH Graz; Abteilung für allgemeine Dermatologie

Graz, , Austria

LKH Innsbruck; Universitätsklinik für Dermatologie

Innsbruck, , Austria

Krankenhaus der Elisabethinen Linz; Abteilung für Dermatologie

Linz, , Austria

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

Salzburg, , Austria

LKH Salzburg; Universitätsklinik für Dermatologie

Salzburg, , Austria

Landesklinikum St. Pölten

Sankt Pölten, , Austria

Medizinische Universität Wien; Univ.Klinik für Dermatologie

Vienna, , Austria

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires St-Luc

Brussels, , Belgium

Sint Augustinus Wilrijk

Wilrijk, , Belgium

University Clinical Center of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, , Bosnia and Herzegovina

Instituto Nacional de Cancer - INCa; Pesquisa Clinica

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Hospital A. C. Camargo; Oncologia

São Paulo, São Paulo, Brazil

Hospital Sao Jose

São Paulo, São Paulo, Brazil

District Oncology Dispensary; Department for Oncology and Dermatology

Plovdiv, , Bulgaria

National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic

Sofia, , Bulgaria

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, Canada

Lion'S Gate Hospital

North Vancouver, British Columbia, Canada

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

St. Boniface General Hospital; Medicine

Winnipeg, Manitoba, Canada

QEII HSC; Oncology

Halifax, Nova Scotia, Canada

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, Canada

London Regional Cancer Centre

London, Ontario, Canada

The Ottawa Hospital; Division of Infectious Diseases

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, Canada

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec, Canada

Chuq - Hopital Hotel Dieu de Quebec; Oncology

Québec, Quebec, Canada

Centro Javeriano de Oncología

Bogotá, , Colombia

Fundacion Santa Fe de Bogotá

Bogotá, , Colombia

Clínica Imbanaco; Oncology

Cali, , Colombia

Hospital Pablo Tobon Uribe

Medellin-Antioquia, , Colombia

Clinical Hospital Sisters of Mercy

Zagreb, , Croatia

Masarykův onkologický ústav; Klinika komplexní onkologické péče

Brno, , Czechia

University Hospital; Oncology and Radiotherapy

Hradec Králové, , Czechia

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, , Czechia

Faculty Hospital; Dialysis Unit

Ostrava, , Czechia

1 Lekarska Fakulta Uni Karlovy; 3 Interni Klinika, Labor. Pro Endokrinologii A Metabolismus

Prague, , Czechia

Faculty Hospital Kralovske Vinohrady; Oncology

Prague, , Czechia

Aarhus Universitetshospital; Kræftafdelingen

Aarhus C, , Denmark

Herlev Hospital; Onkologisk afdeling

Herlev, , Denmark

Odense Universitetshospital, Onkologisk Afdeling R

Odense, , Denmark

Hospital Regional Vicente Corral Moscoso, Servicio de Oncología

Cuenca, , Ecuador

Hospital Abel Gilbert Ponton; Oncology

Guayaquil, , Ecuador

Hospital Solca Portoviejo; Oncologia

Portoviejo, , Ecuador

East Tallinn Central Hospital; Clinic of Internal Medicine

Tallinn, , Estonia

North Estonia Medical Centre Foundation; Oncology Center

Tallinn, , Estonia

Tartu University Hospital; Clinic of Hematology and Oncology

Tartu, , Estonia

Helsinki University Central Hospital; Dept of Oncology

Helsinki, , Finland

Tampere University Hospital; Dept of Oncology

Tampere, , Finland

Turku Uni Central Hospital; Oncology Clinics

Turku, , Finland

Uniklinik RWTH Aachen; Klinik für Dermatologie und Allergologie - Hautklinik

Aachen, , Germany

Klinikum Augsburg Süd; Klinik für Dermatologie und Allergologie

Augsburg, , Germany

CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie

Berlin, , Germany

St. Josef-Hospital Klinik f. Dermatologie u. Allergologie

Bochum, , Germany

Elbekliniken Buxtehude; Klinik für Dermatologie

Buxtehude, , Germany

DRK-Krankenhaus; Hautklinik

Chemnitz, , Germany

Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie

Cologne, , Germany

Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

Dresden, , Germany

Universitätsklinikum Düsseldorf; Hautklinik

Düsseldorf, , Germany

HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie

Erfurt, , Germany

Universitätsklinikum Erlangen; Hautklinik

Erlangen, , Germany

Universitätsklinikum Essen

Essen, , Germany

Klinik Johann Wolfgang von Goethe Uni; Klinik fuer Allgemein- und Viszeralchirurgie

Frankfurt, , Germany

Uniklinikum Freiburg Dermatol

Freiburg im Breisgau, , Germany

SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

Gera, , Germany

Universitätsmedizin Göttingen Georg-August-Universität Zentrum Dermatologie

Göttingen, , Germany

Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie

Hamburg, , Germany

Medizinische Hochschule; Hautklinik Linden

Hanover, , Germany

Uni-Hautklinik

Heidelberg, , Germany

Klinikum am Gesundbrunnen; Tumorzentrum

Heilbronn, , Germany

Universitätsklinikum Jena; Klinik für Hautkrankheiten

Jena, , Germany

Klinikum Kassel; Hautklinik

Kassel, , Germany

UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

Kiel, , Germany

Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie

Leipzig, , Germany

Klinikum d.Stadt Ludwigshafen Hautklinik

Ludwigshafen, , Germany

Universitätsklinikum Schleswig-Holstein; Campus Lübeck

Lübeck, , Germany

Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie

Magdeburg, , Germany

Johannes Gutenberg Unis-Klinik; Dept For Dermatology

Mainz, , Germany

Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

Mannheim, , Germany

Universitätsklinikum Marburg Klinik f. Dermatologie

Marburg, , Germany

Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik

Minden, , Germany

Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

München, , Germany

Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie

München, , Germany

Universitätsklinikum Münster

Münster, , Germany

Fachklinik Hornheide; Internistische Onkologie

Münster, , Germany

Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie

Nuremberg, , Germany

Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie

Quedlinburg, , Germany

KLINIKUM VEST GmbH Knappschaftskrankenhaus Abt.Haut- Allergie- Venen- und Umwelterkrankungen

Recklinghausen, , Germany

Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

Regensburg, , Germany

Universitaets-Hautklinik Tuebingen

Tübingen, , Germany

Wilhelm Fresenius Klinik; Klinik f. Dermatologie u. Allergologie

Wiesbaden, , Germany

HELIOS Klinikum Barmen Zentrum Dermatologie Allergologie und Umweltmedizin

Wuppertal, , Germany

Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie

Würzburg, , Germany

Laiko General Hospital; 1St Pathological Clinic

Athens, , Greece

Hospital Hygeia; 1St Oncology Dept.

Athens, , Greece

Univ General Hosp Heraklion; Medical Oncology

Heraklion, , Greece

Metropolitan Hospital; Dept. of Oncology

Piraeus, , Greece

Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika

Budapest, , Hungary

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

Budapest, , Hungary

Debreceni Egyetem OEC; Borgyogyaszati Klinika

Debrecen, , Hungary

Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

Pécs, , Hungary

Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

Szeged, , Hungary

Tata Memorial Hospital; Dept of Medical Oncology

Mumbai, Maharashtra, India

Curie Manavata Cancer Centre

Nashik, Maharashtra, India

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

New Delhi, National Capital Territory of Delhi, India

Basavatarakam Indo-American Cancer Hospital & Research Institute

Hyderabad, , India

Chhatrapati Shahuji Maharaj Medical University; Department of Oncology

Lucknow, , India

Regional Cancer Centre; Dept of Oncology

Trivandrum, , India

Christian Med Clg & Hspt

Vellore, , India

Cork Uni Hospital; Oncology Dept

Cork, , Ireland

St Vincent'S Uni Hospital; Medical Oncology

Dublin, , Ireland

Mater Misericordiae Uni Hospital; Oncology

Dublin, , Ireland

Mater Private Hospital

Dublin, , Ireland

St James' Hospital; Cancer Clinical Trials Office

Dublin, , Ireland

Galway Uni Hospital; Oncology Dept

Galway, , Ireland

University Hospital Limerick - Oncology

Limerick, , Ireland

Waterford Regional Hospital; Department Of Medical Oncology

Waterford, , Ireland

Soroka Medical Center; Oncology Dept

Beersheba, , Israel

Ranbam Health Care Campus; Oncology - Hafia

Hafia, , Israel

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, , Israel

Chaim Sheba Medical Center; Oncology Dept

Ramat Gan, , Israel

Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

Bari, Apulia, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, Campania, Italy

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

Meldola, Emilia-Romagna, Italy

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena, Emilia-Romagna, Italy

AO Santa Maria Nuova; U.O. Day Hospital di Oncologi

Reggio Emilia, Emilia-Romagna, Italy

A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

Udine, Friuli Venezia Giulia, Italy

Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

Rome, Lazio, Italy

IFO - Istituto Regina Elena; Oncologia Medica

Rome, Lazio, Italy

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

Genoa, Liguria, Italy

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, Italy

Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

Brescia, Lombardy, Italy

Irccs Ospedale San Raffaele;Oncologia Medica

Milan, Lombardy, Italy

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

Milan, Lombardy, Italy

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milan, Lombardy, Italy

Policlinico Le Molinette; Clinica Dermatologica

Turin, Piedmont, Italy

Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1

Palermo, Sicily, Italy

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Florence, Tuscany, Italy

Azienda Ospedaliera S. Chiara; Dip di Onc,Trapianti e delle Nuove Tecnologie in Medicina

Pisa, Tuscany, Italy

A.O.U. Senese Policlinico Santa Maria Alle Scotte

Siena, Tuscany, Italy

Azienda Ospedaliera S. Maria - Terni; Oncologia

Terni, Umbria, Italy

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

Padua, Veneto, Italy

Daugavpils Regional Hospital

Daugavpils, , Latvia

Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

Riga, , Latvia

Klaipeda University Hospital

Klaipėda, , Lithuania

Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

Vilnius, , Lithuania

Fundación Rodolfo Padilla Padilla, A.C.; Oncology

León, , Mexico

Hospital General de México; Unidad de Oncologia

Mexico City, , Mexico

Inst. Nacional de Cancerologia; Investigacion Clinica

Mexico City, , Mexico

Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

Amsterdam, , Netherlands

VU MEDISCH CENTRUM; Dept. of Medical Oncology

Amsterdam, , Netherlands

Tergooiziekenhuizen

Blaricum, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

Academ Ziekenhuis Groningen; Medical Oncology

Groningen, , Netherlands

Academisch Ziekenhuis Leiden; Clinical Oncology

Leiden, , Netherlands

Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

Maastricht, , Netherlands

UMC St Radboud; Interne Oncologie; Medical Oncology Department

Nijmegen, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.

Utrecht, , Netherlands

University Clinic for Radiotherapy and Oncology Skopje; Department of skin malignancies

Skopje, , North Macedonia

Haukeland Universitetshospital; Onkologisk Avd.

Bergen, , Norway

The Norvegian Radium Hospital Montebello; Dept of Oncology

Oslo, , Norway

Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

Arequipa, , Peru

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

Krakow, , Poland

ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37

Olsztyn, , Poland

NZOZ Med.-Polonia sp. z o.o.

Poznan, , Poland

Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie

Warsaw, , Poland

IPO de Lisboa; Servico de Oncologia Medica

Lisbon, , Portugal

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Institut of Oncology Al. Trestioreanu Bucharest; Oncology

Bucharest, , Romania

Medisprof SRL

Cluj-Napoca, , Romania

S.C. Life Search S.R.L; Medical Oncology Clinic

Timișoara, , Romania

FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF

Saint Petersburg, Sankt-Peterburg, Russia

Regional Clinical Oncology Dispensary

Krasnodar, , Russia

Russian Cancer Research Center

Moscow, , Russia

Moscow city oncology hospital #62 of Moscow Healthcare Department

Moscow, , Russia

St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Stavropol Clinical Oncology Dispansary

Stavropol, , Russia

Bashkirian Republican Clinical Oncology Dispensary

Ufa, , Russia

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, , Serbia

Clinical Center Bezanijska Kosa; Oncology

Belgrade, , Serbia

Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie

Bratislava, , Slovakia

Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E

Bratislava, , Slovakia

POKO Poprad; Department of Oncology

Poprad, , Slovakia

Institute of Oncology Ljubljana

Ljubljana, , Slovenia

Universitas Annex, University of the Free State; Clinical Oncology

Bloemfontein, , South Africa

Cape Town Oncology Trials

Cape Town, , South Africa

Cancercare

Cape Town, , South Africa

Medical Oncology Centre of Rosebank; Oncology

Johannesburg, , South Africa

Steve Biko Academic Hospital; Oncology

Pretoria, , South Africa

Sandton Oncology Centre

Sandton, , South Africa

Samsung Medical Center

Seoul, , South Korea

Seoul St Mary's Hospital

Seoul, , South Korea

Seoul National University Hosp; Dept Internal Med Hem Onc

Seoul, , South Korea

Yonsei University Severance Hospital; Medical Oncology

Seoul, , South Korea

Asan Medical Center.

Seoul, , South Korea

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

A Coruña, La Coruña, Spain

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario de Santa Lucía; Servicio de Oncología Médica

Cartagena (Murcia), Murcia, Spain

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarre, Spain

Hospital Xeral Cíes; Servicio de Oncologia

Vigo, Pontevedra, Spain

Hospital Univ. Central de Asturias; Servicio de Oncologia

Oviedo, Principality of Asturias, Spain

Hospital Universitario de Canarias (HUC)

La Laguna (Tenerife), Tenerife, Spain

Hospital de Cruces; Servicio de Oncologia

Barakaldo, Vizcaya, Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, , Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Barcelona, , Spain

Hospital Reina Sofia

Córdoba, , Spain

Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

Granada, , Spain

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

León, , Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Málaga, , Spain

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

Málaga, , Spain

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

Salamanca, , Spain

Hospital Universitario Virgen Macarena; Servicio de Oncologia

Seville, , Spain

Hospital General Universitario de Valencia; Servicio de oncologia

Valencia, , Spain

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, , Spain

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, , Spain

Sahlgrenska Universitetssjukhuset; Onkology

Gothenburg, , Sweden

Skånes Onkologiska Klinik, Universitetssjukhuset

Lund, , Sweden

Karolinska Universitetssjukhuset, Solna

Stockholm, , Sweden

Norrlands universitetssjukhus; Onkologkliniken

Umeå, , Sweden

Akademiska sjukhuset, Onkologkliniken

Uppsala, , Sweden

Universitaetsspital Basel; Onkologie

Basel, , Switzerland

Inselspital Bern; Medizinische Onkologie

Bern, , Switzerland

Kantonsspital Graubünden;Onkologie und Hämatologie

Chur, , Switzerland

CHUV; Departement d'Oncologie

Lausanne, , Switzerland

Kantonsspital St. Gallen; Onkologie/Hämatologie

Sankt Gallen, , Switzerland

Universitätsspital Zürich; Dermatologische Klinik

Zurich, , Switzerland

Adana Baskent University Hospital; Medical Oncology

Adana, , Turkey (Türkiye)

Cukurova Uni Faculty of Medicine; Medical Oncology

Adana, , Turkey (Türkiye)

Ankara Uni , Ibn-I Sina Hospital; Oncology Dept

Ankara, , Turkey (Türkiye)

Gazi Uni Medical Faculty Hospital; Oncology Dept

Ankara, , Turkey (Türkiye)

Akdeniz University School of Medicine; General Surgery

Antalya, , Turkey (Türkiye)

Ege University Medical Faculty; Medical Oncology Department

Bornova, İ̇zmi̇r, , Turkey (Türkiye)

Gaziantep University Medical Faculty, Medical Oncology Department

Gaziantep, , Turkey (Türkiye)

Kartal Training and Research Hospital;Medical Oncology Department

Istanbul, , Turkey (Türkiye)

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, , Turkey (Türkiye)

American Hospital, Medical Oncology Department

Istanbul, , Turkey (Türkiye)

Dokuz Eylul Uni ; Medical Oncology

Izmir, , Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sıhhiye, Ankara, , Turkey (Türkiye)

Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

Cambridge, , United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Royal Surrey County Hospital; St. Lukes Cancer Centre

Guildford, , United Kingdom

St James University Hospital

Leeds, , United Kingdom

Royal Marsden Hospital

London, , United Kingdom

Christie Hospital; Breast Cancer Research Office

Manchester, , United Kingdom

Northern Centre for Cancer Care Freeman Hospital; Sir Bobby Robson Cancer Trials Research Centre

Newcastle upon Tyne, , United Kingdom

Mount Vernon Hospital; Centre For Cancer Treatment

Northwood, , United Kingdom

Nottingham University Hospitals City Campus

Nottingham, , United Kingdom

Churchill Hospital; Oxford Cancer and Haematology Centre

Oxford, , United Kingdom

Southampton General Hospital; Medical Oncology

Southampton, , United Kingdom

Singleton Hospital; Oncology

Swansea, , United Kingdom

Countries

Albania; Argentina; Australia; Austria; Belgium; Bosnia and Herzegovina; Brazil; Bulgaria; Canada; Colombia; Croatia; Czechia; Denmark; Ecuador; Estonia; Finland; Germany; Greece; Hungary; India; Ireland; Israel; Italy; Latvia; Lithuania; Mexico; Netherlands; North Macedonia; Norway; Peru; Poland; Portugal; Romania; Russia; Serbia; Slovakia; Slovenia; South Africa; South Korea; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

References

Larkin J, Brown MP, Arance AM, Hauschild A, Queirolo P, Vecchio MD, Ascierto PA, Krajsova I, Schachter J, Neyns B, Garbe C, Sileni VC, Mandala M, Gogas H, Espinosa E, Hospers G, Lorigan P, Nyakas M, Guminski A, Liszkay G, Rutkowski P, Miller W Jr, Donica M, Makrutzki M, Blank C. An open-label, multicentre safety study of vemurafenib in patients with BRAFV600-mutant metastatic melanoma: final analysis and a validated prognostic scoring system. Eur J Cancer. 2019 Jan;107:175-185. doi: 10.1016/j.ejca.2018.11.018. Epub 2018 Dec 20.

Reference Type: DERIVED

PMID: 30580112 (View on PubMed)

Larkin J, Del Vecchio M, Ascierto PA, Krajsova I, Schachter J, Neyns B, Espinosa E, Garbe C, Sileni VC, Gogas H, Miller WH Jr, Mandala M, Hospers GA, Arance A, Queirolo P, Hauschild A, Brown MP, Mitchell L, Veronese L, Blank CU. Vemurafenib in patients with BRAF(V600) mutated metastatic melanoma: an open-label, multicentre, safety study. Lancet Oncol. 2014 Apr;15(4):436-44. doi: 10.1016/S1470-2045(14)70051-8. Epub 2014 Feb 27.

Reference Type: DERIVED

PMID: 24582505 (View on PubMed)

Other Identifiers

2010-023526-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MO25515

Identifier Type: -

Identifier Source: org_study_id