Clinical trial NCT01307397: A Study of Vemurafenib in Participants With Metastatic Melanoma
Official title: An Open-Label, Multicenter Study to Assess the Safety of RO5185426 (Vemurafenib) in Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 3219
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0
timeFrame: Baseline up to 28 days post end of treatment (maximum up to 46 months)
measure: Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation
timeFrame: Baseline up to 28 days post end of treatment (maximum up to 46 months)
measure: Percentage of Participants With AEs of Special Interest
timeFrame: Baseline up to 28 days post end of treatment (maximum up to 46 months)
measure: Mean Cumulative Dose of Vemurafenib
timeFrame: Baseline up to end of treatment or death (maximum up to 46 months)
measure: Duration of Vemurafenib Treatment
timeFrame: Baseline up to end of treatment or death (maximum upto 46 months)
measure: Mean Total Vemurafenib Dose Per Day
timeFrame: Baseline up to end of treatment or death (maximum up to 46 months)
measure: Dose Intensity of Vemurafenib
timeFrame: Baseline up to end of treatment or death (maximum upto 46 months)
Secondary outcomes:
measure: Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status
timeFrame: Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)
measure: Percentage of Participants Who Received Any Concomitant Medications
timeFrame: Baseline up to 46 months
measure: Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
measure: Duration of Response
timeFrame: From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months])
measure: Time to Response
timeFrame: Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
measure: Percentage of Participants With PD Assessed According to RECIST v1.1 or Death
timeFrame: Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
measure: Progression Free Survival (PFS)
timeFrame: Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
measure: Percentage of Participants Who Died
timeFrame: Baseline until death (maximum up to 46 months)
measure: Overall Survival (OS)
timeFrame: Baseline until death (maximum up to 46 months)
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: University "Mother Theresa" Hospital Center; Oncology Department
city: Buenos Aires
country: Argentina
facility: Hospital Britanico; Oncologia
city: Buenos Aires
country: Argentina
facility: Fundación CIDEA
city: Buenos Aires
country: Argentina
facility: Inst. Alexander Fleming; Oncologia
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Mater Misericordiae Hospital; Oncology
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital; Gallipoli Research Centre
state: Queensland
city: Townsville
country: Australia
facility: The Townsville Hospital; Townsville Cancer Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital; Oncology
state: South Australia
city: Geelong
country: Australia
facility: Geelong Hospital; Geelong Cardiology Practice
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre; Medical Oncology
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch; Abteilung für Innere Medizin
city: Graz
country: Austria
facility: LKH Graz; Abteilung für allgemeine Dermatologie
city: Innsbruck
country: Austria
facility: LKH Innsbruck; Universitätsklinik für Dermatologie
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz; Abteilung für Dermatologie
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Salzburg
country: Austria
facility: LKH Salzburg; Universitätsklinik für Dermatologie
city: St. Pölten
country: Austria
facility: Landesklinikum St. Pölten
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Oncology, University Clinical Center Sarajevo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa; Pesquisa Clinica
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital A. C. Camargo; Oncologia
state: SP
city: São Paulo
country: Brazil
facility: Hospital Sao Jose
state: SP
city: Plovdiv
country: Bulgaria
facility: District Oncology Dispensary; Department for Oncology and Dermatology
city: Sofia
country: Bulgaria
facility: National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic
city: Edmonton
country: Canada
facility: Cross Cancer Institute ; Dept of Medical Oncology
state: Alberta
city: North Vancouver
country: Canada
facility: Lion'S Gate Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital; Medicine
state: Manitoba
city: Halifax
country: Canada
facility: QEII HSC; Oncology
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital; Division of Infectious Diseases
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept
state: Ontario
city: Montreal
country: Canada
facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
state: Quebec
city: Quebec City
country: Canada
facility: Chuq - Hopital Hotel Dieu de Quebec; Oncology
state: Quebec
city: Bogota
country: Colombia
facility: Centro Javeriano de Oncología
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogotá
city: Cali
country: Colombia
facility: Clínica Imbanaco; Oncology
city: Medellin-Antioquia
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Zagreb
country: Croatia
facility: Clinical Hospital Sisters of Mercy
city: Brno
country: Czechia
facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče
city: Hradec Kralove
country: Czechia
facility: University Hospital; Oncology and Radiotherapy
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Ostrava
country: Czechia
facility: Faculty Hospital; Dialysis Unit
city: Praha
country: Czechia
facility: 1 Lekarska Fakulta Uni Karlovy; 3 Interni Klinika, Labor. Pro Endokrinologii A Metabolismus
city: Praha
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady; Oncology
city: Aarhus C
country: Denmark
facility: Aarhus Universitetshospital; Kræftafdelingen
city: Herlev
country: Denmark
facility: Herlev Hospital; Onkologisk afdeling
city: Odense
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Cuenca
country: Ecuador
facility: Hospital Regional Vicente Corral Moscoso, Servicio de Oncología
city: Guayaquil
country: Ecuador
facility: Hospital Abel Gilbert Ponton; Oncology
city: Portoviejo
country: Ecuador
facility: Hospital Solca Portoviejo; Oncologia
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital; Clinic of Internal Medicine
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation; Oncology Center
city: Tartu
country: Estonia
facility: Tartu University Hospital; Clinic of Hematology and Oncology
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Dept of Oncology
city: Tampere
country: Finland
facility: Tampere University Hospital; Dept of Oncology
city: Turku
country: Finland
facility: Turku Uni Central Hospital; Oncology Clinics
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen; Klinik für Dermatologie und Allergologie - Hautklinik
city: Augsburg
country: Germany
facility: Klinikum Augsburg Süd; Klinik für Dermatologie und Allergologie
city: Berlin
country: Germany
facility: CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
city: Bochum
country: Germany
facility: St. Josef-Hospital Klinik f. Dermatologie u. Allergologie
city: Buxtehude
country: Germany
facility: Elbekliniken Buxtehude; Klinik für Dermatologie
city: Chemnitz
country: Germany
facility: DRK-Krankenhaus; Hautklinik
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf; Hautklinik
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Hautklinik
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Klinik fuer Allgemein- und Viszeralchirurgie
city: Freiburg
country: Germany
facility: Uniklinikum Freiburg Dermatol
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität Zentrum Dermatologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie
city: Hannover
country: Germany
facility: Medizinische Hochschule; Hautklinik Linden
city: Heidelberg
country: Germany
facility: Uni-Hautklinik
city: Heilbronn
country: Germany
facility: Klinikum am Gesundbrunnen; Tumorzentrum
city: Jena
country: Germany
facility: Universitätsklinikum Jena; Klinik für Hautkrankheiten
city: Kassel
country: Germany
facility: Klinikum Kassel; Hautklinik
city: Kiel
country: Germany
facility: UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
city: Köln
country: Germany
facility: Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie
city: Ludwigshafen
country: Germany
facility: Klinikum d.Stadt Ludwigshafen Hautklinik
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie
city: Mainz
country: Germany
facility: Johannes Gutenberg Unis-Klinik; Dept For Dermatology
city: Mannheim
country: Germany
facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg Klinik f. Dermatologie
city: Minden
country: Germany
facility: Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik
city: München
country: Germany
facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
city: München
country: Germany
facility: Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Münster
country: Germany
facility: Fachklinik Hornheide; Internistische Onkologie
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie
city: Recklinghausen
country: Germany
facility: KLINIKUM VEST GmbH Knappschaftskrankenhaus Abt.Haut- Allergie- Venen- und Umwelterkrankungen
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
city: Tübingen
country: Germany
facility: Universitaets-Hautklinik Tuebingen
city: Wiesbaden
country: Germany
facility: Wilhelm Fresenius Klinik; Klinik f. Dermatologie u. Allergologie
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Barmen Zentrum Dermatologie Allergologie und Umweltmedizin
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
city: Athens
country: Greece
facility: Laiko General Hospital; 1St Pathological Clinic
city: Athens
country: Greece
facility: Hospital Hygeia; 1St Oncology Dept.
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion; Medical Oncology
city: Piraeus
country: Greece
facility: Metropolitan Hospital; Dept. of Oncology
city: Budapest
country: Hungary
facility: Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem OEC; Borgyogyaszati Klinika
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika
city: Szeged
country: Hungary
facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
state: Delhi
city: Mumbai
country: India
facility: Tata Memorial Hospital; Dept of Medical Oncology
state: Maharashtra
city: Nashik
country: India
facility: Curie Manavata Cancer Centre
state: Maharashtra
city: Hyderabad
country: India
facility: Basavatarakam Indo-American Cancer Hospital & Research Institute
city: Lucknow
country: India
facility: Chhatrapati Shahuji Maharaj Medical University; Department of Oncology
city: Trivandrum
country: India
facility: Regional Cancer Centre; Dept of Oncology
city: Vellore
country: India
facility: Christian Med Clg & Hspt
city: Cork
country: Ireland
facility: Cork Uni Hospital; Oncology Dept
city: Dublin
country: Ireland
facility: St Vincent'S Uni Hospital; Medical Oncology
city: Dublin
country: Ireland
facility: Mater Misericordiae Uni Hospital; Oncology
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Dublin
country: Ireland
facility: St James' Hospital; Cancer Clinical Trials Office
city: Galway
country: Ireland
facility: Galway Uni Hospital; Oncology Dept
city: Limerick
country: Ireland
facility: University Hospital Limerick - Oncology
city: Waterford
country: Ireland
facility: Waterford Regional Hospital; Department Of Medical Oncology
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Oncology Dept
city: Hafia
country: Israel
facility: Ranbam Health Care Campus; Oncology - Hafia
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital; Oncology Dept
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Oncologia
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: AO Santa Maria Nuova; U.O. Day Hospital di Oncologi
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica
state: Lazio
city: Roma
country: Italy
facility: IFO - Istituto Regina Elena; Oncologia Medica
state: Lazio
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
state: Liguria
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII; Oncologia Medica
state: Lombardia
city: Brescia
country: Italy
facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
state: Lombardia
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele;Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
state: Lombardia
city: Torino
country: Italy
facility: Policlinico Le Molinette; Clinica Dermatologica
state: Piemonte
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
state: Puglia
city: Palermo
country: Italy
facility: Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliera S. Chiara; Dip di Onc,Trapianti e delle Nuove Tecnologie in Medicina
state: Toscana
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte
state: Toscana
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria - Terni; Oncologia
state: Umbria
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
state: Veneto
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hosp; Dept Internal Med Hem Onc
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center.
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Riga
country: Latvia
facility: Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: University Clinic for Radiotherapy and Oncology Skopje; Department of skin malignancies
city: Leon
country: Mexico
facility: Fundación Rodolfo Padilla Padilla, A.C.; Oncology
city: Mexico City
country: Mexico
facility: Inst. Nacional de Cancerologia; Investigacion Clinica
city: Mexico DF
country: Mexico
facility: Hospital General de México; Unidad de Oncologia
city: Amsterdam
country: Netherlands
facility: Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
city: Amsterdam
country: Netherlands
facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology
city: Blaricum
country: Netherlands
facility: Tergooiziekenhuizen
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Groningen
country: Netherlands
facility: Academ Ziekenhuis Groningen; Medical Oncology
city: Leiden
country: Netherlands
facility: Academisch Ziekenhuis Leiden; Clinical Oncology
city: Maastricht
country: Netherlands
facility: Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
city: Nijmegen
country: Netherlands
facility: UMC St Radboud; Interne Oncologie; Medical Oncology Department
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
city: Bergen
country: Norway
facility: Haukeland Universitetshospital; Onkologisk Avd.
city: Oslo
country: Norway
facility: The Norvegian Radium Hospital Montebello; Dept of Oncology
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
city: Olsztyn
country: Poland
facility: ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
city: Poznań
country: Poland
facility: NZOZ Med.-Polonia sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
city: Lisboa
country: Portugal
facility: IPO de Lisboa; Servico de Oncologia Medica
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Bucuresti
country: Romania
facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Timisoara
country: Romania
facility: S.C. Life Search S.R.L; Medical Oncology Clinic
city: St Petersburg
country: Russian Federation
facility: FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF
state: Leningrad
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Center
city: Moscow
country: Russian Federation
facility: Moscow city oncology hospital #62 of Moscow Healthcare Department
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
city: Stavropol
country: Russian Federation
facility: Stavropol Clinical Oncology Dispansary
city: UFA
country: Russian Federation
facility: Bashkirian Republican Clinical Oncology Dispensary
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia; Medical Oncology
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa; Oncology
city: Bratislava
country: Slovakia
facility: Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E
city: Poprad
country: Slovakia
facility: POKO Poprad; Department of Oncology
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Bloemfontein
country: South Africa
facility: Universitas Annex, University of the Free State; Clinical Oncology
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials
city: Cape Town
country: South Africa
facility: Cancercare
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank; Oncology
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital; Oncology
city: Sandton
country: South Africa
facility: Sandton Oncology Centre
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Oncologia
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
state: Cantabria
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
state: Las Palmas
city: Cartagena (Murcia)
country: Spain
facility: Hospital Universitario de Santa Lucía; Servicio de Oncología Médica
state: Murcia
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oncologia
state: Navarra
city: Vigo
country: Spain
facility: Hospital Xeral Cíes; Servicio de Oncologia
state: Pontevedra
city: La Laguna (Tenerife)
country: Spain
facility: Hospital Universitario de Canarias (HUC)
state: Tenerife
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia; Servicio de oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset; Onkology
city: Lund
country: Sweden
facility: Skånes Onkologiska Klinik, Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Solna
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus; Onkologkliniken
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Onkologkliniken
city: Basel
country: Switzerland
facility: Universitaetsspital Basel; Onkologie
city: Bern
country: Switzerland
facility: Inselspital Bern; Medizinische Onkologie
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden;Onkologie und Hämatologie
city: Lausanne
country: Switzerland
facility: CHUV; Departement d'Oncologie
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen; Onkologie/Hämatologie
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich; Dermatologische Klinik
city: Adana
country: Turkey
facility: Adana Baskent University Hospital; Medical Oncology
city: Adana
country: Turkey
facility: Cukurova Uni Faculty of Medicine; Medical Oncology
city: Ankara
country: Turkey
facility: Ankara Uni , Ibn-I Sina Hospital; Oncology Dept
city: Ankara
country: Turkey
facility: Gazi Uni Medical Faculty Hospital; Oncology Dept
city: Antalya
country: Turkey
facility: Akdeniz University School of Medicine; General Surgery
city: Bornova, İZMİR
country: Turkey
facility: Ege University Medical Faculty; Medical Oncology Department
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty, Medical Oncology Department
city: Istanbul
country: Turkey
facility: Kartal Training and Research Hospital;Medical Oncology Department
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Istanbul
country: Turkey
facility: American Hospital, Medical Oncology Department
city: Izmir
country: Turkey
facility: Dokuz Eylul Uni ; Medical Oncology
city: Sıhhiye, ANKARA
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
city: Cambridge
country: United Kingdom
facility: Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital; St. Lukes Cancer Centre
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital; Breast Cancer Research Office
city: Newcastle upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care Freeman Hospital; Sir Bobby Robson Cancer Trials Research Centre
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital; Centre For Cancer Treatment
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
city: Oxford
country: United Kingdom
facility: Churchill Hospital; Oxford Cancer and Haematology Centre
city: Southampton
country: United Kingdom
facility: Southampton General Hospital; Medical Oncology
city: Swansea
country: United Kingdom
facility: Singleton Hospital; Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.