Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.

PHASE2CompletedINTERVENTIONAL
Enrollment

177

Participants

Timeline

Start Date

August 5, 2011

Primary Completion Date

October 1, 2015

Study Completion Date

January 7, 2021

Conditions
Cancer
Interventions
DRUG

Dabrafenib

Dabrafenib study treatment was provided as 50 mg and 75 mg hydroxypropyl methylcellulose (HPMC) capsules. Each capsule contains 50 mg or 75 mg of free base (present as the mesylate salt)

DRUG

Trametinib

Trametinib study treatment was provided as 0.5 mg and 2 mg tablets. Each tablet contained 0.5 mg or 2 mg of trametinib parent (present as the dimethyl sulfoxide solvate)

Trial Locations (50)

1081

Novartis Investigative Site, Amsterdam

9713

Novartis Investigative Site, Groningen

10043

Novartis Investigative Site, Orbassano

10065

Novartis Investigative Site, New York

13915

Novartis Investigative Site, Marseille

14033

Novartis Investigative Site, Caen

15232

Novartis Investigative Site, Pittsburgh

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

21231

Novartis Investigative Site, Baltimore

22927

Novartis Investigative Site, Großhansdorf

28006

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

31008

Novartis Investigative Site, Pamplona

31059

Novartis Investigative Site, Toulouse

33612

Novartis Investigative Site, Tampa

40705

Novartis Investigative Site, Taichung

41013

Novartis Investigative Site, Seville

43210

Novartis Investigative Site, Columbus

44805

Novartis Investigative Site, Saint-Herblain

47441

Novartis Investigative Site, Moers

53792

Novartis Investigative Site, Madison

59037

Novartis Investigative Site, Lille

60487

Novartis Investigative Site, Frankfurt am Main

63110

Novartis Investigative Site, St Louis

67091

Novartis Investigative Site, Strasbourg

69126

Novartis Investigative Site, Heidelberg

69495

Novartis Investigative Site, Pierre-Bénite

80045

Novartis Investigative Site, Aurora

90033

Novartis Investigative Site, Los Angeles

92868

Novartis Investigative Site, Orange

94805

Novartis Investigative Site, Villejuif

98109

Novartis Investigative Site, Seattle

02114

Novartis Investigative Site, Boston

02215

Novartis Investigative Site, Boston

48109-5848

Novartis Investigative Site, Ann Arbor

03756

Novartis Investigative Site, Lebanon

534-0021

Novartis Investigative Site, Osaka

104-0045

Novartis Investigative Site, Tokyo

0310

Novartis Investigative Site, Oslo

110-744

Novartis Investigative Site, Seoul

120-752

Novartis Investigative Site, Seoul

135-710

Novartis Investigative Site, Seoul

08025

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

Unknown

Novartis Investigative Site, Taipei

SW3 6JJ

Novartis Investigative Site, London

OX3 7LJ

Novartis Investigative Site, Oxford

SM2 5PT

Novartis Investigative Site, Sutton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY