A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

423

Participants

Timeline

Start Date

May 4, 2012

Primary Completion Date

August 26, 2013

Study Completion Date

February 28, 2019

Conditions
Melanoma
Interventions
DRUG

Dabrafenib

Dabrafenib 150 mg twice daily

DRUG

Trametinib

Trametinib 2 mg once daily

DRUG

Trametinib placebo

Dabrafenib 150 mg twice daily and trametinib placebo

Trial Locations (121)

2060

Novartis Investigative Site, North Sydney

2145

Novartis Investigative Site, Westmead

3084

Novartis Investigative Site, Heidelberg

4102

Novartis Investigative Site, Woolloongabba

5000

Novartis Investigative Site, Adelaide

6009

Novartis Investigative Site, Nedlands

10060

Novartis Investigative Site, Candiolo (TO)

10065

Novartis Investigative Site, New York

10117

Novartis Investigative Site, Berlin

11527

Novartis Investigative Site, Athens

13385

Novartis Investigative Site, Marseille

16132

Novartis Investigative Site, Genoa

19104

Novartis Investigative Site, Philadelphia

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

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Novartis Investigative Site, Buxtehude

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Novartis Investigative Site, Richmond

23538

Novartis Investigative Site, Lübeck

24105

Novartis Investigative Site, Kiel

24127

Novartis Investigative Site, Bergamo

28034

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

29009

Novartis Investigative Site, Khmelnytskyi

29210

Novartis Investigative Site, Columbia

30625

Novartis Investigative Site, Hanover

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Novartis Investigative Site, Pamplona

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Novartis Investigative Site, Toulouse

33075

Novartis Investigative Site, Bordeaux

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Novartis Investigative Site, West Palm Beach

33612

Novartis Investigative Site, Tampa

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Novartis Investigative Site, St. Petersburg

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Novartis Investigative Site, Fort Myers

35033

Novartis Investigative Site, Marburg

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Novartis Investigative Site, Padua

37203

Novartis Investigative Site, Nashville

37404

Novartis Investigative Site, Chattanooga

39120

Novartis Investigative Site, Magdeburg

40005

Novartis Investigative Site, Sumy

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Novartis Investigative Site, Essen

45242

Novartis Investigative Site, Cincinnati

46010

Novartis Investigative Site, Valencia

46202

Novartis Investigative Site, Indianapolis

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Novartis Investigative Site, Dnipropetrovsk

49102

Novartis Investigative Site, Dnipropetrovsk

50937

Novartis Investigative Site, Cologne

53127

Novartis Investigative Site, Bonn

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

55131

Novartis Investigative Site, Mainz

64283

Novartis Investigative Site, Darmstadt

66421

Novartis Investigative Site, Homburg

68167

Novartis Investigative Site, Mannheim

69120

Novartis Investigative Site, Heidelberg

69373

Novartis Investigative Site, Lyon

72076

Novartis Investigative Site, Tübingen

74078

Novartis Investigative Site, Heilbronn

75006

Novartis Investigative Site, Paris

75018

Novartis Investigative Site, Paris

75475

Novartis Investigative Site, Paris

76104

Novartis Investigative Site, Fort Worth

79031

Novartis Investigative Site, Lviv

80337

Novartis Investigative Site, Munich

80804

Novartis Investigative Site, Munich

81675

Novartis Investigative Site, Munich

83092

Novartis Investigative Site, Donetsk

85258

Novartis Investigative Site, Scottsdale

85719

Novartis Investigative Site, Tucson

86179

Novartis Investigative Site, Augsburg

89081

Novartis Investigative Site, Ulm

90024

Novartis Investigative Site, Los Angeles

90419

Novartis Investigative Site, Nuremberg

91054

Novartis Investigative Site, Erlangen

92100

Novartis Investigative Site, Boulogne-Billancourt

93053

Novartis Investigative Site, Regensburg

97080

Novartis Investigative Site, Würzburg

99089

Novartis Investigative Site, Erfurt

143423

Novartis Investigative Site, Moscow

197758

Novartis Investigative Site, Saint Petersburg

355047

Novartis Investigative Site, Stavropol

420029

Novartis Investigative Site, Kazan'

61615-7822

Novartis Investigative Site, Peoria

02114

Novartis Investigative Site, Boston

02215

Novartis Investigative Site, Boston

C1425DTG

Novartis Investigative Site, CABA

C1426ANZ

Novartis Investigative Site, Capital Federal

C1050AAK

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires

T6G 1Z2

Novartis Investigative Site, Edmonton

L8V 5C2

Novartis Investigative Site, Hamilton

N6A 4L6

Novartis Investigative Site, London

M5G 2M9

Novartis Investigative Site, Toronto

H2W 1S6

Novartis Investigative Site, Montreal

H3A 1A1

Novartis Investigative Site, Montreal

01307

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

07548

Novartis Investigative Site, Gera

07740

Novartis Investigative Site, Jena

185 47

Novartis Investigative Site, N. Faliro

564 29

Novartis Investigative Site, Thessaloniki

00144

Novartis Investigative Site, Rome

00167

Novartis Investigative Site, Rome

1066 CX

Novartis Investigative Site, Amsterdam

1081 HV

Novartis Investigative Site, Amsterdam

8025 AB

Novartis Investigative Site, Zwolle

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

SE-413 45

Novartis Investigative Site, Gothenburg

SE-221 85

Novartis Investigative Site, Lund

SE-171 76

Novartis Investigative Site, Stockholm

SE-751 85

Novartis Investigative Site, Uppsala

03022

Novartis Investigative Site, Kyiv

HA6 2RN

Novartis Investigative Site, Northwood

SM2 5PT

Novartis Investigative Site, Sutton

AB25 2ZN

Novartis Investigative Site, Aberdeen

CH63 4JY

Novartis Investigative Site, Bebington

B15 2TH

Novartis Investigative Site, Edgbaston, Birmingham

LS9 7TF

Novartis Investigative Site, Leeds

SW3 6JJ

Novartis Investigative Site, London

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

NG5 1PB

Novartis Investigative Site, Nottingham

OX3 7LJ

Novartis Investigative Site, Oxford

PR2 9HT

Novartis Investigative Site, Preston

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY