A Study of Vemurafenib in Participants With Metastatic Melanoma

Malignant Melanoma Clinical Trial

Official title:

An Open-Label, Multicenter Study to Assess the Safety of RO5185426 (Vemurafenib) in Patients With Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307397
• Other study ID #: MO25515
• Secondary ID: 2010-023526-21
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2011
• Last updated: July 21, 2017
• Start date: March 1, 2011
• Est. completion date: February 24, 2016

Study information

• Verified date: July 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3219
• Est. completion date: February 24, 2016
• Est. primary completion date: February 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Albania	University "Mother Theresa" Hospital Center; Oncology Department	Tirana
Argentina	Fundación CIDEA	Buenos Aires
Argentina	Hospital Britanico; Oncologia	Buenos Aires
Argentina	Inst. Alexander Fleming; Oncologia	Buenos Aires
Australia	Royal Adelaide Hospital; Oncology	Adelaide	South Australia
Australia	Geelong Hospital; Geelong Cardiology Practice	Geelong	Victoria
Australia	Greenslopes Private Hospital; Gallipoli Research Centre	Greenslopes	Queensland
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre; Medical Oncology	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Melanoma Institute Australia	North Sydney	New South Wales
Australia	The Townsville Hospital; Townsville Cancer Centre	Townsville	Queensland
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	Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology	Woolloongabba	Queensland
Austria	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	St. Pölten
Austria	Medizinische Universität Wien; Univ.Klinik für Dermatologie	Wien
Belgium	UZ Brussel	Brussel
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	Sint Augustinus Wilrijk	Wilrijk
Bosnia and Herzegovina	University Clinical Center of the Republic of Srpska	Banja Luka
Bosnia and Herzegovina	Clinic of Oncology, University Clinical Center Sarajevo	Sarajevo
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Instituto Nacional de Cancer - INCa; Pesquisa Clinica	Rio de Janeiro	RJ
Brazil	Hospital A. C. Camargo; Oncologia	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Brazil	Hospital Sao Jose	São Paulo	SP
Bulgaria	District Oncology Dispensary; Department for Oncology and Dermatology	Plovdiv
Bulgaria	National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic	Sofia
Canada	Cross Cancer Institute ; Dept of Medical Oncology	Edmonton	Alberta
Canada	QEII HSC; Oncology	Halifax	Nova Scotia
Canada	Hamilton Health Sciences - Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology	Montreal	Quebec
Canada	Lion'S Gate Hospital	North Vancouver	British Columbia
Canada	The Ottawa Hospital; Division of Infectious Diseases	Ottawa	Ontario
Canada	Chuq - Hopital Hotel Dieu de Quebec; Oncology	Quebec City	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network; Princess Margaret Hospital; Medical Oncology Dept	Toronto	Ontario
Canada	British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	St. Boniface General Hospital; Medicine	Winnipeg	Manitoba
Colombia	Centro Javeriano de Oncología	Bogota
Colombia	Fundacion Santa Fe de Bogotá	Bogota
Colombia	Clínica Imbanaco; Oncology	Cali
Colombia	Hospital Pablo Tobon Uribe	Medellin-Antioquia
Croatia	Clinical Hospital Sisters of Mercy	Zagreb
Czechia	Masarykuv onkologický ústav; Klinika komplexní onkologické péce	Brno
Czechia	University Hospital; Oncology and Radiotherapy	Hradec Kralove
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	Praha
Czechia	Faculty Hospital Kralovske Vinohrady; Oncology	Praha
Denmark	Aarhus Universitetshospital; Kræftafdelingen	Aarhus C
Denmark	Herlev Hospital; Onkologisk afdeling	Herlev
Denmark	Odense Universitetshospital, Onkologisk Afdeling R	Odense
Ecuador	Hospital Regional Vicente Corral Moscoso, Servicio de Oncología	Cuenca
Ecuador	Hospital Abel Gilbert Ponton; Oncology	Guayaquil
Ecuador	Hospital Solca Portoviejo; Oncologia	Portoviejo
Estonia	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
Finland	Helsinki University Central Hospital; Dept of Oncology	Helsinki
Finland	Tampere University Hospital; Dept of Oncology	Tampere
Finland	Turku Uni Central Hospital; Oncology Clinics	Turku
Germany	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	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
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	Hannover
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	Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie	Köln
Germany	Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie	Leipzig
Germany	Universitätsklinikum Schleswig-Holstein; Campus Lübeck	Lübeck
Germany	Klinikum d.Stadt Ludwigshafen Hautklinik	Ludwigshafen
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	Fachklinik Hornheide; Internistische Onkologie	Münster
Germany	Universitätsklinikum Münster	Münster
Germany	Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie	Nürnberg
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
Greece	Hospital Hygeia; 1St Oncology Dept.	Athens
Greece	Laiko General Hospital; 1St Pathological Clinic	Athens
Greece	Univ General Hosp Heraklion; Medical Oncology	Heraklion
Greece	Metropolitan Hospital; Dept. of Oncology	Piraeus
Hungary	Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly	Budapest
Hungary	Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika	Budapest
Hungary	Debreceni Egyetem OEC; Borgyogyaszati Klinika	Debrecen
Hungary	Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika	Pecs
Hungary	Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.	Szeged
India	Basavatarakam Indo-American Cancer Hospital & Research Institute	Hyderabad
India	Chhatrapati Shahuji Maharaj Medical University; Department of Oncology	Lucknow
India	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	Delhi
India	Regional Cancer Centre; Dept of Oncology	Trivandrum
India	Christian Med Clg & Hspt	Vellore
Ireland	Cork Uni Hospital; Oncology Dept	Cork
Ireland	Mater Misericordiae Uni Hospital; Oncology	Dublin
Ireland	Mater Private Hospital	Dublin
Ireland	St James' Hospital; Cancer Clinical Trials Office	Dublin
Ireland	St Vincent'S Uni Hospital; Medical Oncology	Dublin
Ireland	Galway Uni Hospital; Oncology Dept	Galway
Ireland	University Hospital Limerick - Oncology	Limerick
Ireland	Waterford Regional Hospital; Department Of Medical Oncology	Waterford
Israel	Soroka Medical Center; Oncology Dept	Beer Sheva
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
Italy	Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari	Bari	Puglia
Italy	Asst Papa Giovanni XXIII; Oncologia Medica	Bergamo	Lombardia
Italy	Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina	Brescia	Lombardia
Italy	Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1	Firenze	Toscana
Italy	IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A	Genova	Liguria
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica	Milano	Lombardia
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2	Milano	Lombardia
Italy	Irccs Ospedale San Raffaele;Oncologia Medica	Milano	Lombardia
Italy	A.O. Universitaria Policlinico Di Modena; Oncologia	Modena	Emilia-Romagna
Italy	Istituto Nazionale Tumori Fondazione G. Pascale	Napoli	Campania
Italy	IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda	Padova	Veneto
Italy	Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1	Palermo	Sicilia
Italy	Azienda Ospedaliera S. Chiara; Dip di Onc,Trapianti e delle Nuove Tecnologie in Medicina	Pisa	Toscana
Italy	AO Santa Maria Nuova; U.O. Day Hospital di Oncologi	Reggio Emilia	Emilia-Romagna
Italy	IFO - Istituto Regina Elena; Oncologia Medica	Roma	Lazio
Italy	Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica	Roma	Lazio
Italy	A.O.U. Senese Policlinico Santa Maria Alle Scotte	Siena	Toscana
Italy	Azienda Ospedaliera S. Maria - Terni; Oncologia	Terni	Umbria
Italy	Policlinico Le Molinette; Clinica Dermatologica	Torino	Piemonte
Italy	A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia	Udine	Friuli-Venezia Giulia
Korea, Republic of	Asan Medical Center.	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hosp; Dept Internal Med Hem Onc	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital; Medical Oncology	Seoul
Latvia	Daugavpils Regional Hospital	Daugavpils
Latvia	Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs	Riga
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center	Vilnius
Macedonia, The Former Yugoslav Republic of	University Clinic for Radiotherapy and Oncology Skopje; Department of skin malignancies	Skopje
Mexico	Fundación Rodolfo Padilla Padilla, A.C.; Oncology	Leon
Mexico	Inst. Nacional de Cancerologia; Investigacion Clinica	Mexico City
Mexico	Hospital General de México; Unidad de Oncologia	Mexico DF
Netherlands	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
Norway	Haukeland Universitetshospital; Onkologisk Avd.	Bergen
Norway	The Norvegian Radium Hospital Montebello; Dept of Oncology	Oslo
Peru	Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology	Arequipa
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Poland	Szpital Uniwersytecki w Krakowie, Oddzial 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.Sklodowskiej-Curie	Warszawa
Portugal	IPO de Lisboa; Servico de Oncologia Medica	Lisboa
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Romania	Institut of Oncology Al. Trestioreanu Bucharest; Oncology	Bucuresti
Romania	Medisprof SRL	Cluj-Napoca
Romania	S.C. Life Search S.R.L; Medical Oncology Clinic	Timisoara
Russian Federation	Regional Clinical Oncology Dispensary	Krasnodar
Russian Federation	Moscow city oncology hospital #62 of Moscow Healthcare Department	Moscow
Russian Federation	Russian Cancer Research Center	Moscow
Russian Federation	St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary	Saint-Petersburg
Russian Federation	FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF	St Petersburg	Leningrad
Russian Federation	Stavropol Clinical Oncology Dispansary	Stavropol
Russian Federation	Bashkirian Republican Clinical Oncology Dispensary	UFA
Serbia	Clinical Center Bezanijska Kosa; Oncology	Belgrade
Serbia	Institute for Oncology and Radiology of Serbia; Medical Oncology	Belgrade
Slovakia	Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E	Bratislava
Slovakia	Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie	Bratislava
Slovakia	POKO Poprad; Department of Oncology	Poprad
Slovenia	Institute of Oncology Ljubljana	Ljubljana
South Africa	Universitas Annex, University of the Free State; Clinical Oncology	Bloemfontein
South Africa	Cancercare	Cape Town
South Africa	Cape Town Oncology Trials	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
Spain	Hospital de Cruces; Servicio de Oncologia	Barakaldo	Vizcaya
Spain	Hospital Clínic i Provincial; Servicio de Hematología y Oncología	Barcelona
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Barcelona
Spain	Hospital Universitario de Santa Lucía; Servicio de Oncología Médica	Cartagena (Murcia)	Murcia
Spain	Hospital Reina Sofia	Cordoba
Spain	Hospital Universitario Virgen de las Nieves; Servicio de Oncologia	Granada
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología	La Coruña
Spain	Hospital Universitario de Canarias (HUC)	La Laguna (Tenerife)	Tenerife
Spain	Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia	Las Palmas de Gran Canaria	Las Palmas
Spain	Complejo Asistencial Universitario de Leon; Servicio de Oncologia	Leon
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga
Spain	Hospital Regional Universitario Carlos Haya; Servicio de Oncologia	Malaga
Spain	Hospital Univ. Central de Asturias; Servicio de Oncologia	Oviedo	Asturias
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Clinica Universitaria de Navarra; Servicio de Oncologia	Pamplona	Navarra
Spain	Hospital Clinico Universitario de Salamanca; Servicio de Oncologia	Salamanca
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Oncologia	Santander	Cantabria
Spain	Hospital Universitario Virgen Macarena; Servicio de Oncologia	Sevilla
Spain	Hospital General Universitario de Valencia; Servicio de oncologia	Valencia
Spain	Instituto Valenciano Oncologia; Oncologia Medica	Valencia
Spain	Hospital Xeral Cíes; Servicio de Oncologia	Vigo	Pontevedra
Spain	Hospital Universitario Miguel Servet; Servicio Oncologia	Zaragoza
Sweden	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
Switzerland	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	St. Gallen
Switzerland	Universitätsspital Zürich; Dermatologische Klinik	Zürich
Turkey	Adana Baskent University Hospital; Medical Oncology	Adana
Turkey	Cukurova Uni Faculty of Medicine; Medical Oncology	Adana
Turkey	Ankara Uni , Ibn-I Sina Hospital; Oncology Dept	Ankara
Turkey	Gazi Uni Medical Faculty Hospital; Oncology Dept	Ankara
Turkey	Akdeniz University School of Medicine; General Surgery	Antalya
Turkey	Ege University Medical Faculty; Medical Oncology Department	Bornova, IZMIR
Turkey	Gaziantep University Medical Faculty, Medical Oncology Department	Gaziantep
Turkey	American Hospital, Medical Oncology Department	Istanbul
Turkey	Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology	Istanbul
Turkey	Kartal Training and Research Hospital;Medical Oncology Department	Istanbul
Turkey	Dokuz Eylul Uni ; Medical Oncology	Izmir
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye, ANKARA
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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,  Korea, Republic of,  Latvia,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Mexico,  Netherlands,  Norway,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the NCI-CTCAE version 4.0, where Grade 1 indicates "Mild" severity and Grade 5 indicates "Death". The CTCAE defines Grades 3 and 4 as follows: Grade 3 means "Severe"; Inability to work or perform normal daily activity; treatment or medical intervention is indicated in order to improve the overall well-being or symptoms; delaying the onset of treatment is not putting the survival of the participant at direct risk. Grade 4 means "Life-threatening, Disabling"; based on extreme limitation in activity; significant medical intervention/therapy required; and hospitalization probable.	Baseline up to 28 days post end of treatment (maximum up to 46 months)
Primary	Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation	An AE was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Pre existing conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Percentage of participants with dose interruption or discontinuation due to AE was presented.	Baseline up to 28 days post end of treatment (maximum up to 46 months)
Primary	Percentage of Participants With AEs of Special Interest	AEs of special interest included cutaneous squamous cell carcinoma (SCC), rash, photosensitivity, liver injury, arthralgia, fatigue, gastrointestinal (GI) polyps, pancreatitis, potentiation of radiation toxicity, prolongation of cardiac repolarization or arrhythmia, non-cutaneous SCC and other primary malignancies (other than cutaneous SCC or new primary melanoma).	Baseline up to 28 days post end of treatment (maximum up to 46 months)
Primary	Mean Cumulative Dose of Vemurafenib		Baseline up to end of treatment or death (maximum up to 46 months)
Primary	Duration of Vemurafenib Treatment	Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.; Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation.	Baseline up to end of treatment or death (maximum upto 46 months)
Primary	Mean Total Vemurafenib Dose Per Day	Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.; Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. Average total dose per day: total actual dose taken divided by total actual days on treatment.	Baseline up to end of treatment or death (maximum up to 46 months)
Primary	Dose Intensity of Vemurafenib	Dose intensity was defined as (total actual doses taken/total planned doses) *100, where total planned doses = prescribed doses * planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.	Baseline up to end of treatment or death (maximum upto 46 months)
Secondary	Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status	ECOG Performance Status was measured on-therapy assessed participant's performance status on 5 point scale: 0 = fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Percentage of participants who had at least one point improvement from baseline at any assessment visit as well as at last study visit was reported.	Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)
Secondary	Percentage of Participants Who Received Any Concomitant Medications	Concomitant medications were all medications taken during the study, including those started before but ongoing at first dose. No medications for Melanoma were included. Percentage of participants who received at least one concomitant medication was reported.	Baseline up to 46 months
Secondary	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)	BOR was assessed by the investigator according to RECIST v1.1. BOR was defined as having confirmed CR or PR. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions.; Confirmed responses were those that persisted on repeat imaging greater than or equal to (>=) 4 weeks after initial response.	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])
Secondary	Duration of Response	The duration of response was defined as the time between the date of first confirmed CR or PR and date of first progression of disease (PD), or death, from any cause. Responses were assessed as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response. PD: at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.	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])
Secondary	Time to Response	Time to response was defined as the time between the date of first treatment and date of first confirmed CR or PR (assessed as per RECIST v1.1). CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response.	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])
Secondary	Percentage of Participants With PD Assessed According to RECIST v1.1 or Death	PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.	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])
Secondary	Progression Free Survival (PFS)	PFS was defined as the time between the date of the first treatment and the date of first progression or death from any cause. PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.	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])
Secondary	Percentage of Participants Who Died		Baseline until death (maximum up to 46 months)
Secondary	Overall Survival (OS)	Overall Survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.	Baseline until death (maximum up to 46 months)