A Study of Vemurafenib in Participants With Metastatic Melanoma
An Open-Label, Multicenter Study to Assess the Safety of RO5185426 (Vemurafenib) in Patients With Metastatic Melanoma
2 other identifiers
interventional
3,219
39 countries
258
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2011
Longer than P75 for phase_3
258 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2016
CompletedResults Posted
Study results publicly available
December 18, 2017
CompletedDecember 18, 2017
July 1, 2017
5 years
February 17, 2011
July 21, 2017
July 21, 2017
Conditions
Outcome Measures
Primary Outcomes (7)
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)
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)
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)
Mean Cumulative Dose of Vemurafenib
Baseline up to end of treatment or death (maximum up to 46 months)
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)
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)
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 Outcomes (9)
Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status
Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)
Percentage of Participants Who Received Any Concomitant Medications
Baseline up to 46 months
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)
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])
Duration of Response
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])
Time to 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])
- +4 more secondary outcomes
Study Arms (1)
Vemurafenib
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (280)
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, 1000, Albania
Hospital Britanico; Oncologia
Buenos Aires, C1280AEB, Argentina
Fundación CIDEA
Buenos Aires, C1425DTG, Argentina
Inst. Alexander Fleming; Oncologia
Buenos Aires, C1426ANZ, Argentina
Melanoma Institute Australia
North Sydney, New South Wales, 2060, Australia
Newcastle Mater Misericordiae Hospital; Oncology
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Border Medical Oncology
Wodonga, New South Wales, 3690, Australia
Greenslopes Private Hospital; Gallipoli Research Centre
Greenslopes, Queensland, 4120, Australia
The Townsville Hospital; Townsville Cancer Centre
Townsville, Queensland, 4812, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital; Oncology
Adelaide, South Australia, 5000, Australia
Geelong Hospital; Geelong Cardiology Practice
Geelong, Victoria, 3220, Australia
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria, 3000, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Landeskrankenhaus Feldkirch; Abteilung für Innere Medizin
Feldkirch, 6807, Austria
LKH Graz; Abteilung für allgemeine Dermatologie
Graz, 8036, Austria
LKH Innsbruck; Universitätsklinik für Dermatologie
Innsbruck, 6020, Austria
Krankenhaus der Elisabethinen Linz; Abteilung für Dermatologie
Linz, 4020, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, 5020, Austria
LKH Salzburg; Universitätsklinik für Dermatologie
Salzburg, 5020, Austria
Landesklinikum St. Pölten
Sankt Pölten, 3100, Austria
Medizinische Universität Wien; Univ.Klinik für Dermatologie
Vienna, 1090, Austria
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
University Clinical Center of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
Instituto Nacional de Cancer - INCa; Pesquisa Clinica
Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Hospital A. C. Camargo; Oncologia
São Paulo, São Paulo, 01509-010, Brazil
Hospital Sao Jose
São Paulo, São Paulo, CEP 01321-001, Brazil
District Oncology Dispensary; Department for Oncology and Dermatology
Plovdiv, 4000, Bulgaria
National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic
Sofia, 1756, Bulgaria
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, T6G 1Z2, Canada
Lion'S Gate Hospital
North Vancouver, British Columbia, V7L 2L7, Canada
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
St. Boniface General Hospital; Medicine
Winnipeg, Manitoba, R2H 2A6, Canada
QEII HSC; Oncology
Halifax, Nova Scotia, B3H 2Y9, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital; Division of Infectious Diseases
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2, Canada
Chuq - Hopital Hotel Dieu de Quebec; Oncology
Québec, Quebec, G1R 2J6, 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, 10000, Croatia
Masarykův onkologický ústav; Klinika komplexní onkologické péče
Brno, 656 53, Czechia
University Hospital; Oncology and Radiotherapy
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
Faculty Hospital; Dialysis Unit
Ostrava, 708 52, Czechia
1 Lekarska Fakulta Uni Karlovy; 3 Interni Klinika, Labor. Pro Endokrinologii A Metabolismus
Prague, 128 00, Czechia
Faculty Hospital Kralovske Vinohrady; Oncology
Prague, Czechia
Aarhus Universitetshospital; Kræftafdelingen
Aarhus C, 8000, Denmark
Herlev Hospital; Onkologisk afdeling
Herlev, 2730, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense, 5000, Denmark
Hospital Regional Vicente Corral Moscoso, Servicio de Oncología
Cuenca, Ecuador
Hospital Abel Gilbert Ponton; Oncology
Guayaquil, EC090104, Ecuador
Hospital Solca Portoviejo; Oncologia
Portoviejo, EC130104, Ecuador
East Tallinn Central Hospital; Clinic of Internal Medicine
Tallinn, 11312, Estonia
North Estonia Medical Centre Foundation; Oncology Center
Tallinn, 13419, Estonia
Tartu University Hospital; Clinic of Hematology and Oncology
Tartu, 50406, Estonia
Helsinki University Central Hospital; Dept of Oncology
Helsinki, 00029, Finland
Tampere University Hospital; Dept of Oncology
Tampere, 33520, Finland
Turku Uni Central Hospital; Oncology Clinics
Turku, 20520, Finland
Uniklinik RWTH Aachen; Klinik für Dermatologie und Allergologie - Hautklinik
Aachen, 52074, Germany
Klinikum Augsburg Süd; Klinik für Dermatologie und Allergologie
Augsburg, 86179, Germany
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
Berlin, 12200, Germany
St. Josef-Hospital Klinik f. Dermatologie u. Allergologie
Bochum, 44791, Germany
Elbekliniken Buxtehude; Klinik für Dermatologie
Buxtehude, 21614, Germany
DRK-Krankenhaus; Hautklinik
Chemnitz, 09117, Germany
Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie
Cologne, 50937, Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf; Hautklinik
Düsseldorf, 40225, Germany
HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie
Erfurt, 99089, Germany
Universitätsklinikum Erlangen; Hautklinik
Erlangen, 91054, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Klinik Johann Wolfgang von Goethe Uni; Klinik fuer Allgemein- und Viszeralchirurgie
Frankfurt, 60596, Germany
Uniklinikum Freiburg Dermatol
Freiburg im Breisgau, 79104, Germany
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Gera, 07548, Germany
Universitätsmedizin Göttingen Georg-August-Universität Zentrum Dermatologie
Göttingen, 37075, Germany
Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie
Hamburg, 20246, Germany
Medizinische Hochschule; Hautklinik Linden
Hanover, 30449, Germany
Uni-Hautklinik
Heidelberg, 69115, Germany
Klinikum am Gesundbrunnen; Tumorzentrum
Heilbronn, 74078, Germany
Universitätsklinikum Jena; Klinik für Hautkrankheiten
Jena, 07743, Germany
Klinikum Kassel; Hautklinik
Kassel, 34125, Germany
UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
Kiel, 24105, Germany
Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie
Leipzig, 04103, Germany
Klinikum d.Stadt Ludwigshafen Hautklinik
Ludwigshafen, 67063, Germany
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Lübeck, 23538, Germany
Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie
Magdeburg, 39120, Germany
Johannes Gutenberg Unis-Klinik; Dept For Dermatology
Mainz, 55131, Germany
Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
Mannheim, 68167, Germany
Universitätsklinikum Marburg Klinik f. Dermatologie
Marburg, 35043, Germany
Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik
Minden, 32429, Germany
Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
München, 80337, Germany
Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
München, 80804, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Fachklinik Hornheide; Internistische Onkologie
Münster, 48157, Germany
Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
Nuremberg, 90419, Germany
Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie
Quedlinburg, 06484, Germany
KLINIKUM VEST GmbH Knappschaftskrankenhaus Abt.Haut- Allergie- Venen- und Umwelterkrankungen
Recklinghausen, 45657, Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
Regensburg, 93053, Germany
Universitaets-Hautklinik Tuebingen
Tübingen, 72076, Germany
Wilhelm Fresenius Klinik; Klinik f. Dermatologie u. Allergologie
Wiesbaden, 65191, Germany
HELIOS Klinikum Barmen Zentrum Dermatologie Allergologie und Umweltmedizin
Wuppertal, 42283, Germany
Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
Würzburg, 97080, Germany
Laiko General Hospital; 1St Pathological Clinic
Athens, 115 27, Greece
Hospital Hygeia; 1St Oncology Dept.
Athens, 15123, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion, 711 10, Greece
Metropolitan Hospital; Dept. of Oncology
Piraeus, 185 47, Greece
Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika
Budapest, 1085, Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, 1122, Hungary
Debreceni Egyetem OEC; Borgyogyaszati Klinika
Debrecen, 4012, Hungary
Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika
Pécs, 7632, Hungary
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
Szeged, 6720, Hungary
Tata Memorial Hospital; Dept of Medical Oncology
Mumbai, Maharashtra, 400012, India
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004, India
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
New Delhi, National Capital Territory of Delhi, 110085, India
Basavatarakam Indo-American Cancer Hospital & Research Institute
Hyderabad, 500034, India
Chhatrapati Shahuji Maharaj Medical University; Department of Oncology
Lucknow, 226003, India
Regional Cancer Centre; Dept of Oncology
Trivandrum, 695 011, India
Christian Med Clg & Hspt
Vellore, 632004, India
Cork Uni Hospital; Oncology Dept
Cork, Ireland
St Vincent'S Uni Hospital; Medical Oncology
Dublin, 4, Ireland
Mater Misericordiae Uni Hospital; Oncology
Dublin, 7, Ireland
Mater Private Hospital
Dublin, 7, 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, 8410101, Israel
Ranbam Health Care Campus; Oncology - Hafia
Hafia, 3109601, Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, 91120-01, Israel
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, 5262100, Israel
Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
Bari, Apulia, 70126, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, 41100, Italy
AO Santa Maria Nuova; U.O. Day Hospital di Oncologi
Reggio Emilia, Emilia-Romagna, 42100, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine, Friuli Venezia Giulia, 33100, Italy
Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica
Rome, Lazio, 00167, Italy
IFO - Istituto Regina Elena; Oncologia Medica
Rome, Lazio, 00168, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24128, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardy, 25123, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milan, Lombardy, 20132, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, 20133, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milan, Lombardy, 20141, Italy
Policlinico Le Molinette; Clinica Dermatologica
Turin, Piedmont, 10126, Italy
Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
Palermo, Sicily, 90127, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Florence, Tuscany, 50139, Italy
Azienda Ospedaliera S. Chiara; Dip di Onc,Trapianti e delle Nuove Tecnologie in Medicina
Pisa, Tuscany, 50126, Italy
A.O.U. Senese Policlinico Santa Maria Alle Scotte
Siena, Tuscany, 53100, Italy
Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni, Umbria, 05100, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padua, Veneto, 35128, Italy
Daugavpils Regional Hospital
Daugavpils, 5417, Latvia
Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
Riga, LV 1079, Latvia
Klaipeda University Hospital
Klaipėda, 92288, Lithuania
Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
Vilnius, 08661, Lithuania
Fundación Rodolfo Padilla Padilla, A.C.; Oncology
León, 37000, Mexico
Hospital General de México; Unidad de Oncologia
Mexico City, 06726, Mexico
Inst. Nacional de Cancerologia; Investigacion Clinica
Mexico City, 14000, Mexico
Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
Amsterdam, 1066 CX, Netherlands
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, 1081 HV, Netherlands
Tergooiziekenhuizen
Blaricum, 1261 AN, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, 9713 GZ, Netherlands
Academisch Ziekenhuis Leiden; Clinical Oncology
Leiden, 2333 ZA, Netherlands
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
Maastricht, 6229 HX, Netherlands
UMC St Radboud; Interne Oncologie; Medical Oncology Department
Nijmegen, 6500 HB, Netherlands
Erasmus MC
Rotterdam, 3000 CA, Netherlands
Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
Utrecht, 3584 CX, Netherlands
University Clinic for Radiotherapy and Oncology Skopje; Department of skin malignancies
Skopje, 1000, North Macedonia
Haukeland Universitetshospital; Onkologisk Avd.
Bergen, 5021, Norway
The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, 0379, Norway
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Arequipa, 04001, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, 34, Peru
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, 31-531, Poland
ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
Olsztyn, 10-228, Poland
NZOZ Med.-Polonia sp. z o.o.
Poznan, 60-693, Poland
Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
Warsaw, 02-781, Poland
IPO de Lisboa; Servico de Oncologia Medica
Lisbon, 1099-023, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Institut of Oncology Al. Trestioreanu Bucharest; Oncology
Bucharest, 022328, Romania
Medisprof SRL
Cluj-Napoca, 400058, Romania
S.C. Life Search S.R.L; Medical Oncology Clinic
Timișoara, 300167, Romania
FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Regional Clinical Oncology Dispensary
Krasnodar, 350040, Russia
Russian Cancer Research Center
Moscow, 115478, Russia
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, 143423, Russia
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
Stavropol Clinical Oncology Dispansary
Stavropol, ND, Russia
Bashkirian Republican Clinical Oncology Dispensary
Ufa, 450054, Russia
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, 11000, Serbia
Clinical Center Bezanijska Kosa; Oncology
Belgrade, 11080, Serbia
Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie
Bratislava, 812 50, Slovakia
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E
Bratislava, 833 10, Slovakia
POKO Poprad; Department of Oncology
Poprad, 058 01, Slovakia
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
Universitas Annex, University of the Free State; Clinical Oncology
Bloemfontein, 9300, South Africa
Cape Town Oncology Trials
Cape Town, 7570, South Africa
Cancercare
Cape Town, 7700, South Africa
Medical Oncology Centre of Rosebank; Oncology
Johannesburg, 2196, South Africa
Steve Biko Academic Hospital; Oncology
Pretoria, 0002, South Africa
Sandton Oncology Centre
Sandton, 2196, South Africa
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St Mary's Hospital
Seoul, 06591, South Korea
Seoul National University Hosp; Dept Internal Med Hem Onc
Seoul, 110-744, South Korea
Yonsei University Severance Hospital; Medical Oncology
Seoul, 120-752, South Korea
Asan Medical Center.
Seoul, 138-736, South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, La Coruña, 15006, Spain
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario de Santa Lucía; Servicio de Oncología Médica
Cartagena (Murcia), Murcia, 30202, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarre, 31008, Spain
Hospital Xeral Cíes; Servicio de Oncologia
Vigo, Pontevedra, 36312, Spain
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitario de Canarias (HUC)
La Laguna (Tenerife), Tenerife, 38320, Spain
Hospital de Cruces; Servicio de Oncologia
Barakaldo, Vizcaya, 48903, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, 08916, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
Granada, 18014, Spain
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
León, 24071, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, 37007, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, 41009, Spain
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia, 41014, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 46009, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Sahlgrenska Universitetssjukhuset; Onkology
Gothenburg, SE-41 343, Sweden
Skånes Onkologiska Klinik, Universitetssjukhuset
Lund, 22185, Sweden
Karolinska Universitetssjukhuset, Solna
Stockholm, 171 76, Sweden
Norrlands universitetssjukhus; Onkologkliniken
Umeå, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, 75185, Sweden
Universitaetsspital Basel; Onkologie
Basel, 4031, Switzerland
Inselspital Bern; Medizinische Onkologie
Bern, 3010, Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, 7000, Switzerland
CHUV; Departement d'Oncologie
Lausanne, 1011, Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
Sankt Gallen, 9007, Switzerland
Universitätsspital Zürich; Dermatologische Klinik
Zurich, 8091, Switzerland
Adana Baskent University Hospital; Medical Oncology
Adana, 01120, Turkey (Türkiye)
Cukurova Uni Faculty of Medicine; Medical Oncology
Adana, 01330, Turkey (Türkiye)
Ankara Uni , Ibn-I Sina Hospital; Oncology Dept
Ankara, 06230, Turkey (Türkiye)
Gazi Uni Medical Faculty Hospital; Oncology Dept
Ankara, 06500, Turkey (Türkiye)
Akdeniz University School of Medicine; General Surgery
Antalya, 07000, Turkey (Türkiye)
Ege University Medical Faculty; Medical Oncology Department
Bornova, İ̇zmi̇r, 35100, Turkey (Türkiye)
Gaziantep University Medical Faculty, Medical Oncology Department
Gaziantep, 27310, Turkey (Türkiye)
Kartal Training and Research Hospital;Medical Oncology Department
Istanbul, 34000, Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, 34300, Turkey (Türkiye)
American Hospital, Medical Oncology Department
Istanbul, 34365, Turkey (Türkiye)
Dokuz Eylul Uni ; Medical Oncology
Izmir, 35340, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, Ankara, 06100, Turkey (Türkiye)
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
Cambridge, CB2 0QQ, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, GU2 7XX, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL, United Kingdom
Northern Centre for Cancer Care Freeman Hospital; Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, NE7 7DN, United Kingdom
Mount Vernon Hospital; Centre For Cancer Treatment
Northwood, HA6 2RN, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, OX3 7LJ, United Kingdom
Southampton General Hospital; Medical Oncology
Southampton, SO16 6YD, United Kingdom
Singleton Hospital; Oncology
Swansea, SA2 8QA, United Kingdom
Related Publications (2)
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.
PMID: 30580112DERIVEDLarkin 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.
PMID: 24582505DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2011
First Posted
March 2, 2011
Study Start
March 1, 2011
Primary Completion
February 24, 2016
Study Completion
February 24, 2016
Last Updated
December 18, 2017
Results First Posted
December 18, 2017
Record last verified: 2017-07