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A Study of Vemurafenib in Participants With Metastatic Melanoma

Primary Purpose

Malignant Melanoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Vemurafenib

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University "Mother Theresa" Hospital Center; Oncology Department
Hospital Britanico; Oncologia
Fundación CIDEA
Inst. Alexander Fleming; Oncologia
Melanoma Institute Australia
Newcastle Mater Misericordiae Hospital; Oncology
Westmead Hospital
Border Medical Oncology
Greenslopes Private Hospital; Gallipoli Research Centre
The Townsville Hospital; Townsville Cancer Centre
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Royal Adelaide Hospital; Oncology
Geelong Hospital; Geelong Cardiology Practice
Peter MacCallum Cancer Centre; Medical Oncology
Alfred Hospital
Sir Charles Gairdner Hospital
Landeskrankenhaus Feldkirch; Abteilung für Innere Medizin
LKH Graz; Abteilung für allgemeine Dermatologie
LKH Innsbruck; Universitätsklinik für Dermatologie
Krankenhaus der Elisabethinen Linz; Abteilung für Dermatologie
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
LKH Salzburg; Universitätsklinik für Dermatologie
Landesklinikum St. Pölten
Medizinische Universität Wien; Univ.Klinik für Dermatologie
UZ Brussel
Cliniques Universitaires St-Luc
Sint Augustinus Wilrijk
University Clinical Center of the Republic of Srpska
Clinic of Oncology, University Clinical Center Sarajevo
Instituto Nacional de Cancer - INCa; Pesquisa Clinica
Hospital das Clinicas - UFRGS
Instituto do Cancer do Estado de Sao Paulo - ICESP
Hospital A. C. Camargo; Oncologia
Hospital Sao Jose
District Oncology Dispensary; Department for Oncology and Dermatology
National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic
Cross Cancer Institute ; Dept of Medical Oncology
Lion'S Gate Hospital
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
St. Boniface General Hospital; Medicine
QEII HSC; Oncology
Hamilton Health Sciences - Juravinski Cancer Centre
London Regional Cancer Centre
The Ottawa Hospital; Division of Infectious Diseases
Sunnybrook Health Sciences Centre
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Chuq - Hopital Hotel Dieu de Quebec; Oncology
Centro Javeriano de Oncología
Fundacion Santa Fe de Bogotá
Clínica Imbanaco; Oncology
Hospital Pablo Tobon Uribe
Clinical Hospital Sisters of Mercy
Masarykův onkologický ústav; Klinika komplexní onkologické péče
University Hospital; Oncology and Radiotherapy
Fakultni nemocnice Olomouc; Onkologicka klinika
Faculty Hospital; Dialysis Unit
1 Lekarska Fakulta Uni Karlovy; 3 Interni Klinika, Labor. Pro Endokrinologii A Metabolismus
Faculty Hospital Kralovske Vinohrady; Oncology
Aarhus Universitetshospital; Kræftafdelingen
Herlev Hospital; Onkologisk afdeling
Odense Universitetshospital, Onkologisk Afdeling R
Hospital Regional Vicente Corral Moscoso, Servicio de Oncología
Hospital Abel Gilbert Ponton; Oncology
Hospital Solca Portoviejo; Oncologia
East Tallinn Central Hospital; Clinic of Internal Medicine
North Estonia Medical Centre Foundation; Oncology Center
Tartu University Hospital; Clinic of Hematology and Oncology
Helsinki University Central Hospital; Dept of Oncology
Tampere University Hospital; Dept of Oncology
Turku Uni Central Hospital; Oncology Clinics
Uniklinik RWTH Aachen; Klinik für Dermatologie und Allergologie - Hautklinik
Klinikum Augsburg Süd; Klinik für Dermatologie und Allergologie
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
St. Josef-Hospital Klinik f. Dermatologie u. Allergologie
Elbekliniken Buxtehude; Klinik für Dermatologie
DRK-Krankenhaus; Hautklinik
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Universitätsklinikum Düsseldorf; Hautklinik
HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie
Universitätsklinikum Erlangen; Hautklinik
Universitätsklinikum Essen
Klinik Johann Wolfgang von Goethe Uni; Klinik fuer Allgemein- und Viszeralchirurgie
Uniklinikum Freiburg Dermatol
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Universitätsmedizin Göttingen Georg-August-Universität Zentrum Dermatologie
Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie
Medizinische Hochschule; Hautklinik Linden
Uni-Hautklinik
Klinikum am Gesundbrunnen; Tumorzentrum
Universitätsklinikum Jena; Klinik für Hautkrankheiten
Klinikum Kassel; Hautklinik
UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie
Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie
Klinikum d.Stadt Ludwigshafen Hautklinik
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie
Johannes Gutenberg Unis-Klinik; Dept For Dermatology
Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
Universitätsklinikum Marburg Klinik f. Dermatologie
Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik
Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
Universitätsklinikum Münster
Fachklinik Hornheide; Internistische Onkologie
Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie
KLINIKUM VEST GmbH Knappschaftskrankenhaus Abt.Haut- Allergie- Venen- und Umwelterkrankungen
Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
Universitaets-Hautklinik Tuebingen
Wilhelm Fresenius Klinik; Klinik f. Dermatologie u. Allergologie
HELIOS Klinikum Barmen Zentrum Dermatologie Allergologie und Umweltmedizin
Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
Laiko General Hospital; 1St Pathological Clinic
Hospital Hygeia; 1St Oncology Dept.
Univ General Hosp Heraklion; Medical Oncology
Metropolitan Hospital; Dept. of Oncology
Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Debreceni Egyetem OEC; Borgyogyaszati Klinika
Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
Tata Memorial Hospital; Dept of Medical Oncology
Curie Manavata Cancer Centre
Basavatarakam Indo-American Cancer Hospital & Research Institute
Chhatrapati Shahuji Maharaj Medical University; Department of Oncology
Regional Cancer Centre; Dept of Oncology
Christian Med Clg & Hspt
Cork Uni Hospital; Oncology Dept
St Vincent'S Uni Hospital; Medical Oncology
Mater Misericordiae Uni Hospital; Oncology
Mater Private Hospital
St James' Hospital; Cancer Clinical Trials Office
Galway Uni Hospital; Oncology Dept
University Hospital Limerick - Oncology
Waterford Regional Hospital; Department Of Medical Oncology
Soroka Medical Center; Oncology Dept
Ranbam Health Care Campus; Oncology - Hafia
Hadassah Ein Karem Hospital; Oncology Dept
Chaim Sheba Medical Center; Oncology Dept
Istituto Nazionale Tumori Fondazione G. Pascale
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
A.O. Universitaria Policlinico Di Modena; Oncologia
AO Santa Maria Nuova; U.O. Day Hospital di Oncologi
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica
IFO - Istituto Regina Elena; Oncologia Medica
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Asst Papa Giovanni XXIII; Oncologia Medica
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Irccs Ospedale San Raffaele;Oncologia Medica
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Policlinico Le Molinette; Clinica Dermatologica
Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Azienda Ospedaliera S. Chiara; Dip di Onc,Trapianti e delle Nuove Tecnologie in Medicina
A.O.U. Senese Policlinico Santa Maria Alle Scotte
Azienda Ospedaliera S. Maria - Terni; Oncologia
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Samsung Medical Center
Seoul St Mary's Hospital
Seoul National University Hosp; Dept Internal Med Hem Onc
Yonsei University Severance Hospital; Medical Oncology
Asan Medical Center.
Daugavpils Regional Hospital
Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
Klaipeda University Hospital
Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
University Clinic for Radiotherapy and Oncology Skopje; Department of skin malignancies
Fundación Rodolfo Padilla Padilla, A.C.; Oncology
Inst. Nacional de Cancerologia; Investigacion Clinica
Hospital General de México; Unidad de Oncologia
Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Tergooiziekenhuizen
Amphia Ziekenhuis
Academ Ziekenhuis Groningen; Medical Oncology
Academisch Ziekenhuis Leiden; Clinical Oncology
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
UMC St Radboud; Interne Oncologie; Medical Oncology Department
Erasmus MC
Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
Haukeland Universitetshospital; Onkologisk Avd.
The Norvegian Radium Hospital Montebello; Dept of Oncology
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Instituto Nacional de Enfermedades Neoplasicas
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
NZOZ Med.-Polonia sp. z o.o.
Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
IPO de Lisboa; Servico de Oncologia Medica
IPO do Porto; Servico de Oncologia Medica
Institut of Oncology Al. Trestioreanu Bucharest; Oncology
Medisprof SRL
S.C. Life Search S.R.L; Medical Oncology Clinic
FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF
Regional Clinical Oncology Dispensary
Russian Cancer Research Center
Moscow city oncology hospital #62 of Moscow Healthcare Department
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
Stavropol Clinical Oncology Dispansary
Bashkirian Republican Clinical Oncology Dispensary
Institute for Oncology and Radiology of Serbia; Medical Oncology
Clinical Center Bezanijska Kosa; Oncology
Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie
Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E
POKO Poprad; Department of Oncology
Institute of Oncology Ljubljana
Universitas Annex, University of the Free State; Clinical Oncology
Cape Town Oncology Trials
Cancercare
Medical Oncology Centre of Rosebank; Oncology
Steve Biko Academic Hospital; Oncology
Sandton Oncology Centre
Hospital Univ. Central de Asturias; Servicio de Oncologia
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Hospital Universitario Son Espases
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Hospital Universitario de Santa Lucía; Servicio de Oncología Médica
Clinica Universitaria de Navarra; Servicio de Oncologia
Hospital Xeral Cíes; Servicio de Oncologia
Hospital Universitario de Canarias (HUC)
Hospital de Cruces; Servicio de Oncologia
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Hospital Reina Sofia
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
Hospital Ramon y Cajal; Servicio de Oncologia
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Hospital Universitario La Paz; Servicio de Oncologia
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Hospital General Universitario de Valencia; Servicio de oncologia
Instituto Valenciano Oncologia; Oncologia Medica
Hospital Universitario Miguel Servet; Servicio Oncologia
Sahlgrenska Universitetssjukhuset; Onkology
Skånes Onkologiska Klinik, Universitetssjukhuset
Karolinska Universitetssjukhuset, Solna
Norrlands universitetssjukhus; Onkologkliniken
Akademiska sjukhuset, Onkologkliniken
Universitaetsspital Basel; Onkologie
Inselspital Bern; Medizinische Onkologie
Kantonsspital Graubünden;Onkologie und Hämatologie
CHUV; Departement d'Oncologie
Kantonsspital St. Gallen; Onkologie/Hämatologie
Universitätsspital Zürich; Dermatologische Klinik
Adana Baskent University Hospital; Medical Oncology
Cukurova Uni Faculty of Medicine; Medical Oncology
Ankara Uni , Ibn-I Sina Hospital; Oncology Dept
Gazi Uni Medical Faculty Hospital; Oncology Dept
Akdeniz University School of Medicine; General Surgery
Ege University Medical Faculty; Medical Oncology Department
Gaziantep University Medical Faculty, Medical Oncology Department
Kartal Training and Research Hospital;Medical Oncology Department
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
American Hospital, Medical Oncology Department
Dokuz Eylul Uni ; Medical Oncology
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
Beatson West of Scotland Cancer Centre
Royal Surrey County Hospital; St. Lukes Cancer Centre
St James University Hospital
Royal Marsden Hospital
Christie Hospital; Breast Cancer Research Office
Northern Centre for Cancer Care Freeman Hospital; Sir Bobby Robson Cancer Trials Research Centre
Mount Vernon Hospital; Centre For Cancer Treatment
Nottingham University Hospitals City Campus
Churchill Hospital; Oxford Cancer and Haematology Centre
Southampton General Hospital; Medical Oncology
Singleton Hospital; Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vemurafenib

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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).

Mean Cumulative Dose of Vemurafenib

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.

Mean Total Vemurafenib Dose Per Day

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Percentage of Participants Who Died

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.

Full Information

NCT ID

NCT01307397

First Posted

February 17, 2011

Last Updated

July 21, 2017

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01307397

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 1, 2011 (Actual)

Primary Completion Date

February 24, 2016 (Actual)

Study Completion Date

February 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3219 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vemurafenib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vemurafenib

Other Intervention Name(s)

RO5185426, Zelboraf

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline up to 28 days post end of treatment (maximum up to 46 months)

Title

Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation

Description

Time Frame

Baseline up to 28 days post end of treatment (maximum up to 46 months)

Title

Percentage of Participants With AEs of Special Interest

Description

Time Frame

Baseline up to 28 days post end of treatment (maximum up to 46 months)

Title

Mean Cumulative Dose of Vemurafenib

Time Frame

Baseline up to end of treatment or death (maximum up to 46 months)

Title

Duration of Vemurafenib Treatment

Description

Time Frame

Baseline up to end of treatment or death (maximum upto 46 months)

Title

Mean Total Vemurafenib Dose Per Day

Description

Time Frame

Baseline up to end of treatment or death (maximum up to 46 months)

Title

Dose Intensity of Vemurafenib

Description

Time Frame

Baseline up to end of treatment or death (maximum upto 46 months)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status

Description

Time Frame

Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)

Title

Percentage of Participants Who Received Any Concomitant Medications

Description

Time Frame

Baseline up to 46 months

Title

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)

Description

Time Frame

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])

Title

Duration of Response

Description

Time Frame

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])

Title

Time to Response

Description

Time Frame

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])

Title

Percentage of Participants With PD Assessed According to RECIST v1.1 or Death

Description

Time Frame

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])

Title

Progression Free Survival (PFS)

Description

Time Frame

Title

Percentage of Participants Who Died

Time Frame

Baseline until death (maximum up to 46 months)

Title

Overall Survival (OS)

Description

Overall Survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.

Time Frame

Baseline until death (maximum up to 46 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

University "Mother Theresa" Hospital Center; Oncology Department

City

Tirana

ZIP/Postal Code

1000

Country

Albania

Facility Name

Hospital Britanico; Oncologia

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Fundación CIDEA

City

Buenos Aires

ZIP/Postal Code

C1425DTG

Country

Argentina

Facility Name

Inst. Alexander Fleming; Oncologia

City

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Melanoma Institute Australia

City

North Sydney

State/Province

New South Wales

ZIP/Postal Code

2060

Country

Australia

Facility Name

Newcastle Mater Misericordiae Hospital; Oncology

City

Waratah

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Facility Name

Westmead Hospital

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Border Medical Oncology

City

Wodonga

State/Province

New South Wales

ZIP/Postal Code

3690

Country

Australia

Facility Name

Greenslopes Private Hospital; Gallipoli Research Centre

City

Greenslopes

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Facility Name

The Townsville Hospital; Townsville Cancer Centre

City

Townsville

State/Province

Queensland

ZIP/Postal Code

4812

Country

Australia

Facility Name

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Royal Adelaide Hospital; Oncology

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Geelong Hospital; Geelong Cardiology Practice

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

Peter MacCallum Cancer Centre; Medical Oncology

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Sir Charles Gairdner Hospital

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Landeskrankenhaus Feldkirch; Abteilung für Innere Medizin

City

Feldkirch

ZIP/Postal Code

6807

Country

Austria

Facility Name

LKH Graz; Abteilung für allgemeine Dermatologie

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

LKH Innsbruck; Universitätsklinik für Dermatologie

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Krankenhaus der Elisabethinen Linz; Abteilung für Dermatologie

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

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

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

LKH Salzburg; Universitätsklinik für Dermatologie

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Landesklinikum St. Pölten

City

St. Pölten

ZIP/Postal Code

3100

Country

Austria

Facility Name

Medizinische Universität Wien; Univ.Klinik für Dermatologie

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

UZ Brussel

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Cliniques Universitaires St-Luc

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Sint Augustinus Wilrijk

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

University Clinical Center of the Republic of Srpska

City

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

Clinic of Oncology, University Clinical Center Sarajevo

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

Instituto Nacional de Cancer - INCa; Pesquisa Clinica

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20230-130

Country

Brazil

Facility Name

Hospital das Clinicas - UFRGS

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Instituto do Cancer do Estado de Sao Paulo - ICESP

City

Sao Paulo

State/Province

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Hospital A. C. Camargo; Oncologia

City

Sao Paulo

State/Province

ZIP/Postal Code

01509-010

Country

Brazil

Facility Name

Hospital Sao Jose

City

São Paulo

State/Province

ZIP/Postal Code

CEP 01321-001

Country

Brazil

Facility Name

District Oncology Dispensary; Department for Oncology and Dermatology

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Cross Cancer Institute ; Dept of Medical Oncology

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Lion'S Gate Hospital

City

North Vancouver

State/Province

British Columbia

ZIP/Postal Code

V7L 2L7

Country

Canada

Facility Name

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

St. Boniface General Hospital; Medicine

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Facility Name

QEII HSC; Oncology

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Hamilton Health Sciences - Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

London Regional Cancer Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

The Ottawa Hospital; Division of Infectious Diseases

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

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

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Chuq - Hopital Hotel Dieu de Quebec; Oncology

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Centro Javeriano de Oncología

City

Bogota

Country

Colombia

Facility Name

Fundacion Santa Fe de Bogotá

City

Bogota

Country

Colombia

Facility Name

Clínica Imbanaco; Oncology

City

Cali

Country

Colombia

Facility Name

Hospital Pablo Tobon Uribe

City

Medellin-Antioquia

Country

Colombia

Facility Name

Clinical Hospital Sisters of Mercy

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Masarykův onkologický ústav; Klinika komplexní onkologické péče

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

University Hospital; Oncology and Radiotherapy

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc; Onkologicka klinika

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Faculty Hospital; Dialysis Unit

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

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

City

Praha

ZIP/Postal Code

128 00

Country

Czechia

Facility Name

Faculty Hospital Kralovske Vinohrady; Oncology

City

Praha

Country

Czechia

Facility Name

Aarhus Universitetshospital; Kræftafdelingen

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Herlev Hospital; Onkologisk afdeling

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Odense Universitetshospital, Onkologisk Afdeling R

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Hospital Regional Vicente Corral Moscoso, Servicio de Oncología

City

Cuenca

Country

Ecuador

Facility Name

Hospital Abel Gilbert Ponton; Oncology

City

Guayaquil

ZIP/Postal Code

EC090104

Country

Ecuador

Facility Name

Hospital Solca Portoviejo; Oncologia

City

Portoviejo

ZIP/Postal Code

EC130104

Country

Ecuador

Facility Name

East Tallinn Central Hospital; Clinic of Internal Medicine

City

Tallinn

ZIP/Postal Code

11312

Country

Estonia

Facility Name

North Estonia Medical Centre Foundation; Oncology Center

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Tartu University Hospital; Clinic of Hematology and Oncology

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Helsinki University Central Hospital; Dept of Oncology

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Tampere University Hospital; Dept of Oncology

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Turku Uni Central Hospital; Oncology Clinics

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Uniklinik RWTH Aachen; Klinik für Dermatologie und Allergologie - Hautklinik

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Klinikum Augsburg Süd; Klinik für Dermatologie und Allergologie

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

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

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

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

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Elbekliniken Buxtehude; Klinik für Dermatologie

City

Buxtehude

ZIP/Postal Code

21614

Country

Germany

Facility Name

DRK-Krankenhaus; Hautklinik

City

Chemnitz

ZIP/Postal Code

09117

Country

Germany

Facility Name

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

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitätsklinikum Düsseldorf; Hautklinik

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

Universitätsklinikum Erlangen; Hautklinik

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Universitätsklinikum Essen

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

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

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Uniklinikum Freiburg Dermatol

City

Freiburg

ZIP/Postal Code

79104

Country

Germany

Facility Name

SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Universitätsmedizin Göttingen Georg-August-Universität Zentrum Dermatologie

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

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

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Medizinische Hochschule; Hautklinik Linden

City

Hannover

ZIP/Postal Code

30449

Country

Germany

Facility Name

Uni-Hautklinik

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

Klinikum am Gesundbrunnen; Tumorzentrum

City

Heilbronn

ZIP/Postal Code

74078

Country

Germany

Facility Name

Universitätsklinikum Jena; Klinik für Hautkrankheiten

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Klinikum Kassel; Hautklinik

City

Kassel

ZIP/Postal Code

34125

Country

Germany

Facility Name

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

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

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

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Klinikum d.Stadt Ludwigshafen Hautklinik

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Universitätsklinikum Schleswig-Holstein; Campus Lübeck

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Johannes Gutenberg Unis-Klinik; Dept For Dermatology

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Universitätsklinikum Marburg Klinik f. Dermatologie

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik

City

Minden

ZIP/Postal Code

32429

Country

Germany

Facility Name

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

City

München

ZIP/Postal Code

80337

Country

Germany

Facility Name

Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie

City

München

ZIP/Postal Code

80804

Country

Germany

Facility Name

Universitätsklinikum Münster

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Fachklinik Hornheide; Internistische Onkologie

City

Münster

ZIP/Postal Code

48157

Country

Germany

Facility Name

Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie

City

Nürnberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie

City

Quedlinburg

ZIP/Postal Code

06484

Country

Germany

Facility Name

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

City

Recklinghausen

ZIP/Postal Code

45657

Country

Germany

Facility Name

Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Universitaets-Hautklinik Tuebingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Wilhelm Fresenius Klinik; Klinik f. Dermatologie u. Allergologie

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

HELIOS Klinikum Barmen Zentrum Dermatologie Allergologie und Umweltmedizin

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Facility Name

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

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Laiko General Hospital; 1St Pathological Clinic

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Hospital Hygeia; 1St Oncology Dept.

City

Athens

ZIP/Postal Code

15123

Country

Greece

Facility Name

Univ General Hosp Heraklion; Medical Oncology

City

Heraklion

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Metropolitan Hospital; Dept. of Oncology

City

Piraeus

ZIP/Postal Code

185 47

Country

Greece

Facility Name

Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Debreceni Egyetem OEC; Borgyogyaszati Klinika

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

City

Pecs

ZIP/Postal Code

7632

Country

Hungary

Facility Name

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

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110085

Country

India

Facility Name

Tata Memorial Hospital; Dept of Medical Oncology

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400012

Country

India

Facility Name

Curie Manavata Cancer Centre

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422004

Country

India

Facility Name

Basavatarakam Indo-American Cancer Hospital & Research Institute

City

Hyderabad

ZIP/Postal Code

500034

Country

India

Facility Name

Chhatrapati Shahuji Maharaj Medical University; Department of Oncology

City

Lucknow

ZIP/Postal Code

226003

Country

India

Facility Name

Regional Cancer Centre; Dept of Oncology

City

Trivandrum

ZIP/Postal Code

695 011

Country

India

Facility Name

Christian Med Clg & Hspt

City

Vellore

ZIP/Postal Code

632004

Country

India

Facility Name

Cork Uni Hospital; Oncology Dept

City

Cork

Country

Ireland

Facility Name

St Vincent'S Uni Hospital; Medical Oncology

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Mater Misericordiae Uni Hospital; Oncology

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Mater Private Hospital

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

St James' Hospital; Cancer Clinical Trials Office

City

Dublin

Country

Ireland

Facility Name

Galway Uni Hospital; Oncology Dept

City

Galway

Country

Ireland

Facility Name

University Hospital Limerick - Oncology

City

Limerick

Country

Ireland

Facility Name

Waterford Regional Hospital; Department Of Medical Oncology

City

Waterford

Country

Ireland

Facility Name

Soroka Medical Center; Oncology Dept

City

Beer Sheva

ZIP/Postal Code

8410101

Country

Israel

Facility Name

Ranbam Health Care Campus; Oncology - Hafia

City

Hafia

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah Ein Karem Hospital; Oncology Dept

City

Jerusalem

ZIP/Postal Code

91120-01

Country

Israel

Facility Name

Chaim Sheba Medical Center; Oncology Dept

City

Ramat Gan

ZIP/Postal Code

5262100

Country

Israel

Facility Name

Istituto Nazionale Tumori Fondazione G. Pascale

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

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

City

Meldola

State/Province

Emilia-Romagna

ZIP/Postal Code

47014

Country

Italy

Facility Name

A.O. Universitaria Policlinico Di Modena; Oncologia

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41100

Country

Italy

Facility Name

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

City

Reggio Emilia

State/Province

Emilia-Romagna

ZIP/Postal Code

42100

Country

Italy

Facility Name

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

City

Udine

State/Province

Friuli-Venezia Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

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

City

Roma

State/Province

Lazio

ZIP/Postal Code

00167

Country

Italy

Facility Name

IFO - Istituto Regina Elena; Oncologia Medica

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

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

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

Asst Papa Giovanni XXIII; Oncologia Medica

City

Bergamo

State/Province

Lombardia

ZIP/Postal Code

24128

Country

Italy

Facility Name

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

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Irccs Ospedale San Raffaele;Oncologia Medica

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Facility Name

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

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20141

Country

Italy

Facility Name

Policlinico Le Molinette; Clinica Dermatologica

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10126

Country

Italy

Facility Name

Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

City

Bari

State/Province

Puglia

ZIP/Postal Code

70126

Country

Italy

Facility Name

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

City

Palermo

State/Province

Sicilia

ZIP/Postal Code

90127

Country

Italy

Facility Name

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

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50139

Country

Italy

Facility Name

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

City

Pisa

State/Province

Toscana

ZIP/Postal Code

50126

Country

Italy

Facility Name

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

City

Siena

State/Province

Toscana

ZIP/Postal Code

53100

Country

Italy

Facility Name

Azienda Ospedaliera S. Maria - Terni; Oncologia

City

Terni

State/Province

Umbria

ZIP/Postal Code

05100

Country

Italy

Facility Name

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Seoul St Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Seoul National University Hosp; Dept Internal Med Hem Onc

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Yonsei University Severance Hospital; Medical Oncology

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Asan Medical Center.

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Daugavpils Regional Hospital

City

Daugavpils

ZIP/Postal Code

5417

Country

Latvia

Facility Name

Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

City

Riga

ZIP/Postal Code

LV 1079

Country

Latvia

Facility Name

Klaipeda University Hospital

City

Klaipeda

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

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

City

Vilnius

ZIP/Postal Code

08661

Country

Lithuania

Facility Name

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

City

Skopje

ZIP/Postal Code

1000

Country

Macedonia, The Former Yugoslav Republic of

Facility Name

Fundación Rodolfo Padilla Padilla, A.C.; Oncology

City

Leon

ZIP/Postal Code

37000

Country

Mexico

Facility Name

Inst. Nacional de Cancerologia; Investigacion Clinica

City

Mexico City

ZIP/Postal Code

14000

Country

Mexico

Facility Name

Hospital General de México; Unidad de Oncologia

City

Mexico DF

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

VU MEDISCH CENTRUM; Dept. of Medical Oncology

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Tergooiziekenhuizen

City

Blaricum

ZIP/Postal Code

1261 AN

Country

Netherlands

Facility Name

Amphia Ziekenhuis

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Academ Ziekenhuis Groningen; Medical Oncology

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Academisch Ziekenhuis Leiden; Clinical Oncology

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

UMC St Radboud; Interne Oncologie; Medical Oncology Department

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

Facility Name

Erasmus MC

City

Rotterdam

ZIP/Postal Code

3000 CA

Country

Netherlands

Facility Name

Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Haukeland Universitetshospital; Onkologisk Avd.

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

The Norvegian Radium Hospital Montebello; Dept of Oncology

City

Oslo

ZIP/Postal Code

0379

Country

Norway

Facility Name

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

City

Arequipa

ZIP/Postal Code

04001

Country

Peru

Facility Name

Instituto Nacional de Enfermedades Neoplasicas

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

City

Krakow

ZIP/Postal Code

31-531

Country

Poland

Facility Name

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

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

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

City

Poznań

ZIP/Postal Code

60-693

Country

Poland

Facility Name

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

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

IPO de Lisboa; Servico de Oncologia Medica

City

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

IPO do Porto; Servico de Oncologia Medica

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Institut of Oncology Al. Trestioreanu Bucharest; Oncology

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Medisprof SRL

City

Cluj-Napoca

ZIP/Postal Code

400058

Country

Romania

Facility Name

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

City

Timisoara

ZIP/Postal Code

300167

Country

Romania

Facility Name

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

City

St Petersburg

State/Province

Leningrad

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Regional Clinical Oncology Dispensary

City

Krasnodar

ZIP/Postal Code

350040

Country

Russian Federation

Facility Name

Russian Cancer Research Center

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Moscow city oncology hospital #62 of Moscow Healthcare Department

City

Moscow

ZIP/Postal Code

143423

Country

Russian Federation

Facility Name

St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Stavropol Clinical Oncology Dispansary

City

Stavropol

ZIP/Postal Code

Country

Russian Federation

Facility Name

Bashkirian Republican Clinical Oncology Dispensary

City

UFA

ZIP/Postal Code

450054

Country

Russian Federation

Facility Name

Institute for Oncology and Radiology of Serbia; Medical Oncology

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Center Bezanijska Kosa; Oncology

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie

City

Bratislava

ZIP/Postal Code

812 50

Country

Slovakia

Facility Name

Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E

City

Bratislava

ZIP/Postal Code

833 10

Country

Slovakia

Facility Name

POKO Poprad; Department of Oncology

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Institute of Oncology Ljubljana

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Universitas Annex, University of the Free State; Clinical Oncology

City

Bloemfontein

ZIP/Postal Code

9300

Country

South Africa

Facility Name

Cape Town Oncology Trials

City

Cape Town

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Cancercare

City

Cape Town

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Medical Oncology Centre of Rosebank; Oncology

City

Johannesburg

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Steve Biko Academic Hospital; Oncology

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Sandton Oncology Centre

City

Sandton

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Hospital Univ. Central de Asturias; Servicio de Oncologia

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital Universitario Son Espases

City

Palma De Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07014

Country

Spain

Facility Name

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

City

Las Palmas de Gran Canaria

State/Province

Las Palmas

ZIP/Postal Code

35016

Country

Spain

Facility Name

Hospital Universitario de Santa Lucía; Servicio de Oncología Médica

City

Cartagena (Murcia)

State/Province

Murcia

ZIP/Postal Code

30202

Country

Spain

Facility Name

Clinica Universitaria de Navarra; Servicio de Oncologia

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital Xeral Cíes; Servicio de Oncologia

City

Vigo

State/Province

Pontevedra

ZIP/Postal Code

36312

Country

Spain

Facility Name

Hospital Universitario de Canarias (HUC)

City

La Laguna (Tenerife)

State/Province

Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Hospital de Cruces; Servicio de Oncologia

City

Barakaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Hospital Univ Vall d'Hebron; Servicio de Oncologia

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

City

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Reina Sofia

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

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

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

City

Leon

ZIP/Postal Code

24071

Country

Spain

Facility Name

Hospital Ramon y Cajal; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena; Servicio de Oncologia

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Hospital General Universitario de Valencia; Servicio de oncologia

City

Valencia

ZIP/Postal Code

41014

Country

Spain

Facility Name

Instituto Valenciano Oncologia; Oncologia Medica

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Hospital Universitario Miguel Servet; Servicio Oncologia

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Sahlgrenska Universitetssjukhuset; Onkology

City

Gothenburg

ZIP/Postal Code

SE-41 343

Country

Sweden

Facility Name

Skånes Onkologiska Klinik, Universitetssjukhuset

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

Karolinska Universitetssjukhuset, Solna

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Norrlands universitetssjukhus; Onkologkliniken

City

Umeå

Country

Sweden

Facility Name

Akademiska sjukhuset, Onkologkliniken

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Universitaetsspital Basel; Onkologie

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Inselspital Bern; Medizinische Onkologie

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Kantonsspital Graubünden;Onkologie und Hämatologie

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

CHUV; Departement d'Oncologie

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Kantonsspital St. Gallen; Onkologie/Hämatologie

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Universitätsspital Zürich; Dermatologische Klinik

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Adana Baskent University Hospital; Medical Oncology

City

Adana

ZIP/Postal Code

01120

Country

Turkey

Facility Name

Cukurova Uni Faculty of Medicine; Medical Oncology

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Ankara Uni , Ibn-I Sina Hospital; Oncology Dept

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Gazi Uni Medical Faculty Hospital; Oncology Dept

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Akdeniz University School of Medicine; General Surgery

City

Antalya

ZIP/Postal Code

07000

Country

Turkey

Facility Name

Ege University Medical Faculty; Medical Oncology Department

City

Bornova, İZMİR

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Gaziantep University Medical Faculty, Medical Oncology Department

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Kartal Training and Research Hospital;Medical Oncology Department

City

Istanbul

ZIP/Postal Code

34000

Country

Turkey

Facility Name

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

City

Istanbul

ZIP/Postal Code

34300

Country

Turkey

Facility Name

American Hospital, Medical Oncology Department

City

Istanbul

ZIP/Postal Code

34365

Country

Turkey

Facility Name

Dokuz Eylul Uni ; Medical Oncology

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

City

Sıhhiye, ANKARA

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Beatson West of Scotland Cancer Centre

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Royal Surrey County Hospital; St. Lukes Cancer Centre

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

St James University Hospital

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Royal Marsden Hospital

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Christie Hospital; Breast Cancer Research Office

City

Manchester

ZIP/Postal Code

M20 4QL

Country

United Kingdom

Facility Name

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

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Mount Vernon Hospital; Centre For Cancer Treatment

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Nottingham University Hospitals City Campus

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Churchill Hospital; Oxford Cancer and Haematology Centre

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Southampton General Hospital; Medical Oncology

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Singleton Hospital; Oncology

City

Swansea

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30580112

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.

Results Reference

derived

PubMed Identifier

24582505

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.

Results Reference

derived

Learn more about this trial

A Study of Vemurafenib in Participants With Metastatic Melanoma

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