Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

921

Participants

Timeline

Start Date

September 12, 2013

Primary Completion Date

November 9, 2016

Study Completion Date

September 3, 2024

Conditions
Melanoma
Interventions
DRUG

LGX818

LGX818- Orally 100 mg and 50 mg capsules

DRUG

MEK162

MEK162- Orally 15 mg tablets

DRUG

vemurafenib

Tablets in bottles or blisters 240 mg

Trial Locations (282)

27

Mary Potter Oncology Centre, Pretoria

128

Policlinico Universitario Campus Biomedico Di Roma, Rome

379

Oslo universitetssykehus HF, Utprøvingsenheten, Oslo

Oslo universitetssykehus HF, Oslo

3004

The Alfred Hospital, Prahran

3010

Hospital General Universitario Dr. Balmis, Alicante

Inselspital Bern, Bern

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4102

Princess Alexandra Hospital, Woolloongabba

4215

Tasman Oncology Research, Southport

5011

The Queen Elizabeth Hospital, Woodville

6009

Sir Charles Gairdner Hospital, Nedlands

6500

Gazi University Medical Faculty Gazi Hospital, Ankara

8036

Hospital Clinic de Barcelona, Barcelona

8041

Hospital de la Santa Creu I Sant Pau, Barcelona

8058

Universitätsspital Zürich, Zurich Flughafen

10060

Fondazione del Piemonte per l'Oncologia (IRCCS), Candiolo

10117

Charite-Universitaetsmedizin Berlin, Berlin

11407

Hospital Universitario de Jerez, Jerez de la Frontera

14050

Medica Sur, S. A. B de C. V. (Centro de Investigación Farmacológica y Biotecnológica CIF-BIOTEC), México

14080

Instituto Nacional de Cancerologia, Mexico City

14642

Investigational Drug Service, Department of Pharmacy (Investigational Product), Rochester

University of Rochester Medical Center - PPDS, Rochester

15006

Hospital Universitario A Coruña, A Coruña

15232

University of Pittsburgh Cancer Institute, Pittsburgh

16132

IRCCS Az. Osp. Universitaria San Martino- IST, Genoa

Istituto Oncologico Veneto - I.R.C.C.S., Padua

18014

Hospital Universitario Virgen de las Nieves, Granada

20014

Onkologikoa, Donostia / San Sebastian

20133

Istituto Nazionale Dei Tumori, Milan

20141

Istituto Europeo Di Oncologia, Milan

20155

Virginia Cancer Specialists, PC, Gainesville

20162

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda, Milan

20246

Universitätsklinik Hamburg Eppendorf, Hamburg

20900

Azienda Ospedaliera San Gerardo, Monza

21614

Augenarztzentrum Buxtehude, Buxtehude

Elben Klinken Stade ? Buxtehude, Buxtehude

22031

Virginia Cancer Specialists (Leesburg) - USOR, Fairfax

22044

Northern Virginia Ophthalmology Associates, Falls Church

22205

Virginia Cancer Specialists, Arlington

22221

Skanes Universitetssjukhus Lund, Lund

22304

Virginia Cancer Specialists, PC, Alexandria

23538

Universitatsklinikum Schleswig-Holstein, Campus Lubeck, Lübeck

23900

Azienda Ospedaliera Ospedale Di Lecco, Lecco

24105

University Hospital Schleswig-Holstein, Campus Kiel, Kiel

24127

ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

25123

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN, Brescia

25198

Hospital Arnau de Vilanova, Lleida

Hospital Universitari Arnau de Vilanova, Lleida

27100

Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz - PPDS, Madrid

28220

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

29011

Hospital Civil (Hospital Regional Universitario de Malaga), Málaga

30120

Hospital Clinico Universitario Virgen de la Arrixaca, El Palmar

30159

Augenärzte am Kröpcke, Hanover

30625

Medizinische Hochschule Hannover (Hannover Medical School), Hanover

30626

Institut für Diagnostische und Interventionelle Radilogie, Hanover

31008

Clinica Universidad de Navarra, Pamplona

Hospital Universitario de Navarra, Pamplona

32427

Augen-Praxis_Minden, Minden

32429

Institut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin, Minden

Mühlenkreiskliniken - Johannes Wesling Klinikum Minden, Minden

33011

Hospital Universitario Central de Asturias, Oviedo

33075

Hopital Saint Andre Unite de Cancerologie Service de Dermatologie, Bordeaux

33100

Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia, Udine

33136

University of Miami, Miami

33426

University Cancer Institute, Boynton Beach

34125

Klinikum Kassel, Kassel

35100

Ege University Medical Faculty, Bornova

Ege University Medical aculty, Izmir

Sifa Universitesi Bornova Egitim Arastirma Hastanesi, Izmir

35128

Clinica Oculistica, Padua

35233

Retinal Consultants of Alabama P.C., Birmingham

UAB Callahan Eye Hospital, Birmingham

UAB Comprehensive Cancer Center, Birmingham

UAB The Kirklin Clinic, Birmingham

35243

University of Alabama at Birmingham, Birmingham

35294

University of Alabama at Birmingham, Birmingham

37920

University of Tennessee Medical Center Cancer Institute, Knoxville

38010

Hospital Universitario Nuestra Sra de La Candelaria, Santa Cruz de Tenerife

38043

CHU de Grenoble, Grenoble

39120

Universitätsklinikum Magdeburg A.ö.R., Magdeburg

39202

Jackson Oncology Associates - St. Dominic Hospital, Jackson

39401

Hattiesburg Clinic Oncology Hem, Hattiesburg

40138

Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi, Bologna

41013

Hospital Universitario Virgen del Rocio - PPDS, Seville

41014

Hospital Nuestra Señora de Valme, Seville

45147

Universitätsklinikum Essen, Essen

46009

Fundacion Instituto Valenciano de Oncologia, Valencia

46526

Goshen Center For Cancer Care, Goshen

48157

Fachklinik Hornheide Abteilung für Internistische Onkologie und Hämatologie, Münster

49503

Lack's Cancer Center at Mercy Health Saint Mary's, Grand Rapids

Mercy Health Hauenstein Neuroscience Center Neuro-Ophthalmology (Clinic), Grand Rapids

49525

Retina Specialists of Michigan, Grand Rapids

51092

CHU de Reims - Hôpital Robert Debré, Reims

53100

Azienza Ospedaliera Universitaria Senese, Siena

53105

Universitätsklinikum Bonn, Bonn

53127

Augenklinik Universitätsklinikum Bonn, Bonn

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

57104

Sanford Cancer Center Oncology Clinic & Pharmacy, Sioux Falls

59037

CHRU de Lille - Hôpital Huriet, Lille

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi, Torrette Site

60590

Goethe-University Frankfurt/Main, Frankfurt am Main

60612

Eye & Ear Infirmary- Opthalmology, Chicago

University of Illinois at Chicago, Chicago

University of Illinois Hospital and Health Sciences System - Investigational Drug Service, Chicago

University of Illinois Hospital and Health Sciences System, Chicago

University of Illinois Medical Center, Chicago

60714

Oncology Specialists, SC, Niles

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey

66421

Universität des Saarlandes, Homburg

67091

Nouvel Hopital Civil, Strasbourg

68114

Nebraska Methodist Hospital, Omaha

68135

Klinikum Mannheim Universitätsklinikum gGmbH, Mannheim

68167

Augenklinik Universitätsklinikum Mannheim, Mannheim

69120

University Clinic Heidelberg - PPDS, Heidelberg

University Clinic Heidelberg - PPDS, Heidelberg

69373

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes, Lyon

69495

Hospices Civils de Lyon - Hopital Lyon Sud, Pierre-Bénite

70126

IRCCS Giovanni Paolo II Cancer Institute, Bari

70852

Fakultni nemocnice Ostrava, Ostrava

72037

Centre Hospitalier Le Mans, Le Mans

72076

Universitätsklinikum Tübingen, Tübingen

Universitätsklinikum Tübingen, Tübingen

72703

Highlands Oncology Group, Fayetteville

72758

Highlands Oncology Group, Rogers

72762

Highlands Oncology Group - Fayetteville, Springdale

74146

Tulsa Cancer Institute PLLC, Tulsa

75010

Hopital Lariboisiere, Paris

75014

Institut Mutualiste Montsouris, Paris

75015

Ophtalmologist office, Paris

75231

Dr. Dennis B. Kay (Ophthalmologist), Dallas

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

75390

UT Southwestern Medical Center at Dallas, Dallas

75475

Hôpital Saint louis, Paris

75478

Klinik für Augenheilkunde, Gera

77505

Cancun Oncology Center Galenia, Cancún

79104

Universitaetsklinikum Freiburg, Freiburg im Breisgau

79106

Universitätsklinikum Freiburg, Klinik für Radiologie, Freiburg im Breisgau

80012

Rocky Mountain Cancer Centers (Williams) - USOR, Aurora

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale, Napoli

80134

Specialty Eye Care, Parker

80218

Rocky Mountain Cancer Centers (Williams) - USOR, Denver

80228

Rocky Mountain Cancer Centers, Lakewood

80303

Rocky Mountain Cancer Centers, Boulder

80337

LMU Klinikum, München

80907

Rocky Mountain Cancer Centers, Colorado Springs

81008

Rocky Mountain Cancer Centers, Pueblo

85710

Arizona Oncology Associates, Tucson

89070

Universitätsklinikum Ulm, Ulm

89073

Internistische Schwerpunktpraxis Kardiologie Hämatologie Onkologie, Ulm

89081

Universitätsklinikum Ulm, Ulm

90419

Hautklinik, Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität, Nuremberg

Klinikum Nürnberg - Campus Nord, Nuremberg

91120

Hadassah Medical Center - PPDS, Jerusalem

92104

Centre Hospitalier Universitaire Ambroise Paré, Boulogne-Billancourt

92868

UC Irvine Medical Center, Orange

93053

Institut für Röntgendiagnostik, Regensburg

University Clinic Regensburg - PPDS, Regensburg

Klinik & Poliklinik für Augenheilkunde, Regensburg

94805

Institut Gustave Roussy, Villejuif

95445

Klinikum Bayreuth GmbH, Bayreuth

97080

Universitätsklinikum Würzburg, Würzburg

97100

Azienda Ospedaliera Civile Maria Paternò Arezzo Ragusa, Ragusa

S. C. Oncologia Medica Presidio Ospedaliero Maria Paterno Arezzo, Ragusa

98801

Wenatchee Valley Hospital & Clinics, Wenatchee

99089

Klinik fur Hautkrankheiten und Allergologie, Helios Hauttumorzentrum Erfurt, Helios Klinikum Erfurt, Erfurt

110311

Hospital Universitario San Ignacio, Bogotá

115478

Russian Oncology Research Center n a N N Blokhin, Moscow

168583

National Cancer Centre - 30 Hospital Blvd, Singapore

169608

Singapore General Hospital (SGH), Singapore

169610

National Cancer Centre Singapore, Singapore

Singapore National Eye Research Centre, Singapore

197758

Scientific Research Institute of Oncology n.a. N.N. Petrov, Saint Petersburg

390005

Ryazan Clinical Hospital n.a. Semashko, Ryazan

390011

Ryazan Regional Clinical Oncology Dispensary, Ryazan

3109601

Rambam Health Care Campus, Haifa

5262100

Sheba Medical Center - PPDS, Ramat Gan

07601

Hackensack University Medical Center, Hackensack

05401

University of Vermont Medical Center, Burlington

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, CABA

C1025ABI

Fundación Investigar, Buenos Aires

C1426ANZ

Instituto Médico Especializado Alexander Fleming, Buenos Aires

02290

Lake Macquarie Private Hospital, Gateshead

41825-010

AMO - Assistência Multidisciplinar em Oncologia, Salvador

50070-550

Instituto de Medicina Integral Professor Fernando Figueira, Recife

98700-000

Associação Hospital de Caridade Ijuí, Ijuí

90035-003

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre

14784-400

Fundação PIO XII, Barretos

59062-000

Liga Norte Riograndense Contra O Cancer, Natal

20220-410

INCA Instituto Nacional de Cancer, Rio de Janeiro

01321-001

Hospital BP Mirante, São Paulo

T2N 4N2

Tom Baker Cancer Centre, Calgary

M4N 3M5

SunnyBrook Health Sciences Centre, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H2L 4M1

Centre Hospitalier De L'Universite De Montreal Hospital Notre Dame, Montreal

CHUM Notrea Dame Hospital, Montreal

H2X 3E4

Centre Hospitalier de l'Universite de Montreal, Montreal

H4A 3J1

McGill University Health center, Montreal

G1R 2J6

CHU de Quebec-Universite Laval - L' Hotel - Dieu de Quebec, Québec

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

656 53

Mou/Mmci - Ppds, Brno

775 20

Fakultni nemocnice Olomouc, Olomouc

128 08

General Faculty Hospital, Prague

06202

Groupe Hospitalier Archet I Et II, Nice

04103

Universitatsklinikum Leipzig AoR, Leipzig

01307

University Hospital Carl Gustav Carus at the Technical University of Dresden, Dresden

01309

Überörtliche Radiologische Gemeinschaftspraxis Dresden, Dresden

07548

Institut für Diagnostische und Interventionelle Radiologie, Gera

SRH Wald-Klinikum Gera GmbH, Gera

115 27

Laiko General Hospital of Athens, Athens

185 47

Metropolitan Hospital, Neo Faliro

01062

Magyar Honvédség Egészségügyi Központ, Budapest

H-1122

Orszagos Onkologiai Intezet, Budapest

05004

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok

00128

Policlinico Universitario Campus Biomedico Di Roma, Rome

Policlinico Universitario Campus Biomedico, Rome

00144

Istituto Nazionale Tumori Regina Elena, Rome

00167

Istituto Dermopatico dell'Immacolata IRCCS, Rome

05100

Azienda Ospedaliera S Maria Di Terni, Terni

812-8582

Kyushu University Hospital, Fukuoka

390-8621

Shinshu University Hospital, Matsumoto

951-8566

Niigata Cancer Center Hospital, Niigata

104-0045

National Cancer Center Hospital, Chuo-ku

540-0006

National Hospital Organization Osaka National Hospital, Osaka

6525 GA

Radboud University Nijmegen Medical Centre, Nijmegen

4818CK

Amphia Ziekenhuis, Breda

5631 BM

Maxima Medisch Centrum, Eindhoven

1081 HV

VU Medisch Centrum, Amsterdam

7513 ER

Medisch Spectrum Twente, Enschede

8025 AB

Isala Zwolle, Zwolle

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

7513 JX

Medisch Spectrum Twente - Hospital, Ariënsplein Enschede

7512 KZ

Medisch Spectrum Twente, Enschede

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

6419 PC

Zuyderland Medisch Centrum - Heerlen, Heerlen

2300 RC

Leids Universitair Medisch Centrum, Leiden

6229 HX

Maastricht University Medical Center, Maastricht

3015 CE

Erasmus MC, Rotterdam

3075 EA

Erasmus MC-Daniel den Hoed Oncologisch Centrum, Rotterdam

NO-0424

Oslo Myeloma Center - PPDS, Oslo

01-673

Centrum Medyczne MAVIT Sp. z o.o., Warsaw

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie, Warsaw

00-001

Lux Med, Warsaw

1099-023

Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Lisbon

2801-951

Hospital Garcia de Orta*E.P.E., Almada

1649-035

Centro Hospitalar de Lisboa Norte, E.P.E- Hospital de Santa Maria, Lisbon

4200-072

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto

833 10

Narodny onkologicky ustav - PPDS, Bratislava

058 01

POKO POPRAD, s.r.o., Poprad

00002

Steve Biko Academic Hospital, Pretoria

06351

Samsung Medical Center - PPDS, Gangnam-gu

05505

Asan Medical Center - PPDS, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System - PPDS, Seoul

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08029

Cetir, Centre Mèdic, S.L, Barcelona

08021

Centro de Oftalmologia Barraquer, Barcelona

08035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

SE-801 87

Gävle Sjukhus, Gävle

SE-41345

Sahlgrenska Universitetssjukhuset, Gothenburg

581 85

Universitetssjukhuset i Linköping, Linköping

171 64

Karolinska Universitetssjukhuset Solna, Solna

751 85

Uppsala Universitet, Uppsala

CB2 0QQ

Addenbrookes Hospital, Cambridge

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

HA6 2RN

Mount Vernon Hospital, Northwood

GU2 7XX

Royal Surrey County Hospital, Guildford

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington

S10 2SJ

Weston Park Hospital, Sheffield

CM1 7ET

Broomfield Hospital, Broomfield

LS9 7TF

St James University Hospital, Leeds

NW32QG

Royal Free Hospital, London

M20 4BX

The Christie NHS Foundation Trust - PPDS, Manchester

OX3 7LE

Churchill Hospital, Oxford

PR2 9HT

Royal Preston Hospital - NWCRN- PPDS, Preston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01909453 - Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma | Biotech Hunter | Biotech Hunter