Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

July 12, 2013

Primary Completion Date

December 1, 2015

Study Completion Date

June 4, 2019

Conditions
Metastatic or Unresectable Cutaneous Melanoma
Interventions
DRUG

MEK162

MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food.

DRUG

Dacarbazine

Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.

Trial Locations (229)

2050

Chris O'Brien Lifehouse Hospital, Camperdown

2060

Melanoma Institute Australia, North Sydney

2610

Sint-Augustinuskliniek, Wilrijk

3722

Severance Hospital Yonsei University Health System - PPDS, Seoul

4102

Princess Alexandra Hospital, Woolloongabba

10117

Charite Campus Mitte, Berlin

10126

A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro, Torino

13385

Hopitaux de La Timone, Marseille

15006

Hospital Universitario A Coruña, A Coruña

16132

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

17033

Penn State Milton S. Hershey Medical Center, Hershey

18015

Cancer Center Associates - Medical Oncology, Bethlehem

St. Luke's University Hospital - Bethlehem Campus, Bethlehem

18045

St. Luke's Cancer Center - Anderson Campus, Easton

18104

Cancer Center Associates - Medical Oncology, Allentown

St. Luke's Cancer Center - Allentown Campus, Allentown

St. Luke's Hospital - Allentown Campus, Allentown

18951

St. Luke's Hospital - Quakertown Campus, Quakertown

19104

Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine, Philadelphia

19107

Thomas Jefferson Medical Oncology, Philadelphia

Thomas Jefferson University, Philadelphia

20132

Ospedale San Raffaele S.r.l. - PPDS, Milan

20133

Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano, Milan

21237

Harry and Jeannette Weinberg Cancer Institute @Franklin Square, Baltimore

21614

Elben Klinken Stade Buxtehude, Buxtehude

23538

Universitatsklinikum Schleswig-Holstein, Lübeck

24105

Universitatsklinikum Schleswig-Holstein, Kiel

24129

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

25123

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

28009

Hospital General Universitario Gregorio Maranon, Madrid

28033

MD Anderson Cancer Center, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28050

Hospital Universitario HM Sanchinarro - CIOCC, Madrid

29010

Hospital Regional Universitario de Malaga Hospital General, Málaga

30625

Medizinische Hochschule Hannover (Hannover Medical School), Hanover

31008

Clinica Universidad Navarra, Pamplona

32429

Johannes Wesling Klinikum Minden, Minden

32605

Florida Cancer Specialists, Gainesville

32701

Florida Cancer Specialists, Altamonte Springs

32763

Florida Cancer Specialists, Orange City

32778

Florida Cancer Specialists, Tavares

32806

Florida Cancer Specialists, Orlando

33000

Hôpital Saint-André, Bordeaux

33511

Florida Cancer Specialists, Brandon

33607

Florida Cancer Specialists, Tampa

33613

Florida Cancer Specialists, Tampa

33705

Florida Cancer Specialists, St. Petersburg

33707

Florida Cancer Specialists, St. Petersburg

33756

Florida Cancer Specialists, Clearwater

33761

Florida Cancer Specialists, Clearwater

33770

Florida Cancer Specialists, Largo

33777

Florida Cancer Specialists, Largo

33905

Florida Cancer Specialists, Fort Myers

33908

Florida Cancer Specialists, Fort Myers

33914

Florida Cancer Specialists, Cape Coral

33980

Florida Cancer Specialists, Port Charlotte

34098

Istanbul University Cerrahpasa Medical Faculty Hospital, Istanbul

34102

Florida Cancer Specialists, Naples

34119

Florida Cancer Specialists, Naples

34135

Florida Cancer Specialists, Bonita Springs

34209

Florida Cancer Specialists, Bradenton

34232

Florida Cancer Specialists, Sarasota

34236

Florida Cancer Specialists, Sarasota

34285

Florida Cancer Specialists, Venice

34292

Florida Cancer Specialists, Venice

34453

Florida Cancer Specialists, Inverness

34608

Florida Cancer Specialists, Spring Hill

34655

Florida Cancer Specialists, New Port Richey

34667

Florida Cancer Specialists, Hudson

35001

Complejo Hospitalario Universitario Insular - Materno Infantil, Gran Canaria

35100

Ege University Medical Faculty, Bornova

35128

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

37203

Sarah Cannon Research Institute, Nashville

41009

Hospital Universitario Virgen Macarena, Seville

43210

The Ohio State University James Cancer Hospital, Columbus

43221

The Ohio State University Martha Morehouse Medical Plaza, Columbus

45004

Hospital Virgen de La Salud, Toledo

45147

Universitätsklinikum Essen, Essen

46009

Fundacion Instituto Valenciano de Oncologia, Valencia

46014

Consorcio Hospital General Universitario de Valencia, Valencia

46526

Goshen Center For Cancer Care, Goshen

48025

Kresge Eye Institute, Bingham Farms

48157

Fachklinik Hornheide, Münster

48201

Barbara Ann Karmanos Cancer Institute, Detroit

Kresge Eye Institute, Detroit

48334

Karmanos Cancer Institute of Farmington Hills, Farmington Hills

49033

CHU Angers, Angers

50937

Uniklinik Köln, Cologne

51092

Hôpital Robert Debré, Reims

53100

Azienza Ospedaliera Universitaria Senese, Siena

59037

CHRU de Lille - Hôpital Huriet, Lille

60068

Oncology Specialists, SC, Park Ridge

60590

Institut für Diagnostische und Interventionelle Radiologie Frankfurt, Frankfurt am Main

Universitätsklinikum Frankfurt, Frankfurt am Main

60714

Oncology Specialists, SC, Niles

68114

Nebraska Methodist Hospital, Omaha

68135

Klinikum Mannheim Universitätsklinikum gGmbH, Mannheim

69120

University Clinic Heidelberg - PPDS, Heidelberg

69373

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

69495

Service de PneumologieCHU Lyon Sud, Pierre-Bénite

70126

IRCCS Giovanni Paolo II Istituto Oncologico, Bari

72037

Centre Hospitalier Le Mans, Le Mans

72076

Universitätsklinikum Tübingen, Tübingen

72703

Highlands Oncology Group, Fayetteville

72758

Highlands Oncology Group, Rogers

75010

Hôpital Saint Louis, Paris

75230

Elliot J. Ginchansky, MD, PA, Dallas

75231

Dennis B. Kay, Dallas

75235

Parkland Memorial Hospital, Dallas

UT Southwestern University Hospital- St. Paul, Dallas

75246

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

75390

UT Southwestern Medical Center at Dallas, Dallas

UT Southwestern University Hospital - Zale Lipshy, Dallas

76031

Centre Hospitalier Universitaire Hopitaux de Rouen, Rouen

77380

US Oncology, The Woodlands

78731

Texas Oncology-Austin Central, Austin

79104

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80131

Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale, Napoli

80138

AOU dell'Università degli Studi della Campania Luigi Vanvitelli, Napoli

80337

LMU Klinikum der Universität München, München

89081

Universit*ätsklinikum Ulm, Ulm

90419

Klinikum Nuernberg Nord, Nuremberg

91120

Hadassah Medical Center - PPDS, Jerusalem

92100

Centre Hospitalier Universitaire Ambroise Pare, Boulogne-Billancourt

93053

University Clinic Regensburg - PPDS, Regensburg

97080

Universitätsklinikum Würzburg, Würzburg

97201

OHSU Knight Cancer Institute, Portland

97227

Kaiser Permanente Northwest Region Oncology/Hematology, Portland

97239

OHSU Center for Health and Healing, Portland

OHSU, Portland

Oregon Health and Science University, Portland

99089

Helios Klinikum Erfurt, Erfurt

115478

Russian Oncology Research Center n a N N Blokhin, Moscow

197758

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

390011

Ryazan Regional Clinical Oncology Dispensary, Ryazan

1040045

National Cancer Center Hospital, Chūōku

3109601

Rambam Medical Center - PPDS, Haifa

5262100

Sheba Medical Center - PPDS, Ramat Gan

20220410

INCA Instituto Nacional de Cancer, Rio de Janeiro

04401

Eastern Maine Medical Center, Bangor

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

08043

Cooper University Hospital, Voorhees Township

76177-3204

US Oncology, Fort Worth

C1050AAK

Sanatorio de La Providencia, Buenos Aires

08500

Centro de Investigación Clínica ? Clínica Viedma, Viedma

S2000KZE

Centro Oncologico de Rosario, Rosario

C1125ABE

Fundacion CIDEA, Buenos Aires

02290

Lake Macquarie Private Hospital, Gateshead

05000

Royal Adelaide Hospital, Adelaide

08036

LKH-Universitätsklinikum Klinikum Graz, Graz

Hospital Clinic de Barcelona, Barcelona

06020

Universitätsklinikum Innsbruck, Innsbruck

05020

Salzburger Landeskliniken, Salzburg

01090

Allgemeines Krankenhaus der Stadt Wien, Vienna

03000

UZ Gasthuisberg, Leuven

04000

CHU Sart Tilman, Liège

99010-260

Hospital de Clinicas de Passo Fundo, Passo Fundo

90035-903

Hospital Moinhos de Vento, Porto Alegre

90560-030

Hospital Moinhos de Vento, Porto Alegre

01321-001

Hospital São José, São Paulo

T6G 1Z2

Alberta Health Services - Cross Cancer Institute, Edmonton

N6A 4L6

London Regional Cancer Program, London

M4N 3M5

Sunnybrook Research Institute Centre, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H4A 3J1

McGill University Health Center / Royal Victoria Hospital, Montreal

G1R 2J6

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

656 53

Mou/Mmci - Ppds, Brno

708 52

Fakultni nemocnice Ostrava, Ostrava

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

128 08

Vseobecna Fakultni Nemocnice V Praze, Prague

06202

Groupe Hospitalier Archet I Et II, Nice

04103

Universitatsklinikum Leipzig, Leipzig

06484

Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH, Quedlinburg

01307

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden

07548

SRH Wald-Klinikum Gera GmbH, Gera

115 27

Laiko General Hospital of Athens, Athens

01062

Magyar Honvédség Egészségügyi Központ, Budapest

H-1122

Orszagos Onkologiai Intezet, Budapest

07400

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár

05004

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

00167

Istituto Dermopatico dell'Immacolata IRCCS, Rome

00144

Istituto Nazionale Tumori Regina Elena, Roma

390-8621

Shinshu University Hospital, Matsumoto

573-1191

Kansai Medical University Hospital, Hirakata

6525 GA

Radboud University Nijmegen Medical Centre, Nijmegen

1066 CX

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam

2333ZA

Leids Universitair Medisch Centrum, Leiden

8025 AB

Isala Klinieken, Zwolle

01-673

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

02-676

Lux Med, Warsaw

02-781

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Warsaw

1099-023

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

2801-951

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

1649-035

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

4200-072

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

833 01

Narodny onkologicky ustav, Bratislava

09301

University of The Free State, Bloemfontein

02196

Sandton Oncology Medical Group, Johannesburg

02199

Sandton Oncology Medical Research, Johannesburg

00002

Steve Biko Academic Hospital, Pretoria

00027

Mary Potter Oncology Centre, Pretoria

05505

Asan Medical Center - PPDS, Seoul

06351

Samsung Medical Center - PPDS, Seoul

110-744

Seoul National University Hospital, Seoul

08907

ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat

ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona

08035

Hospital Universitario Vall d'Hebrón - PPDS, Barcelona

Unknown

Skanes Universitetssjukhus Lund, Lund

221 85

Skanes Universitetssjukhus Lund, Lund

08091

Universitätsspital Zürich, Zurich

01211

Hôpitaux Universitaires de Genève, Geneva

01011

Centre Hospitalier Universitaire Vaudois, Lausanne

01230

Adana Ba?kent Hastanesi K??la Yerle?kesi, Adana

06100

Hacettepe University Medical Faculty, Ankara

06490

Baskent University Medical Faculty Ankara Hospital, Ankara

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

TR1 3LJ

Royal Cornwall Hospital, Truro

BN2 5BE

The Royal Sussex County Hospital, Brighton

CM1 7ET

Broomfield Hospital, Chelmsford

SA2 8QA

Singleton Hospital - PPDS, Swansea

PR2 9HT

Royal Preston Hospital, Preston

SW3 6JJ

Royal Marsden Hospital - Surrey, London

B15 2TH

Queen Elizabeth Hospital, Birmingham

LS9 7TF

St James s Institute of Clinical Oncology, Leeds

CH63 4JY

Clatterbridge Hospital, Metropolitan Borough of Wirral

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01763164 - Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma | Biotech Hunter | Biotech Hunter