A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 23, 2013

Primary Completion Date

December 4, 2020

Study Completion Date

December 4, 2020

Conditions
Neoplasms, Brain
Interventions
DRUG

Dabrafenib

Dabrafenib is available as 50 mg or 75 mg capsules and as oral suspension (10 mg/mL for subjects unable to swallow capsules). Dabrafenib (either formulation) will be administered orally as a single dose on Day 1 and twice daily from Day 2, based on weight at the appropriate study dose level.

Trial Locations (26)

3052

Novartis Investigative Site, Parkville

10065

Novartis Investigative Site, New York

13353

Novartis Investigative Site, Berlin

13385

Novartis Investigative Site, Marseille

20133

Novartis Investigative Site, Milan

21287

Novartis Investigative Site, Baltimore

28009

Novartis Investigative Site, Madrid

31059

Novartis Investigative Site, Toulouse

45229

Novartis Investigative Site, Cincinnati

52621

Novartis Investigative Site, Ramat Gan

69120

Novartis Investigative Site, Heidelberg

75248

Novartis Investigative Site, Paris

75571

Novartis Investigative Site, Paris

91120

Novartis Investigative Site, Jerusalem

92868

Novartis Investigative Site, Orange

93053

Novartis Investigative Site, Regensburg

94805

Novartis Investigative Site, Villejuif

98105

Novartis Investigative Site, Seattle

85016-7710

Novartis Investigative Site, Phoenix

02215

Novartis Investigative Site, Boston

38105-3678

Novartis Investigative Site, Memphis

M5G 1X8

Novartis Investigative Site, Toronto

DK-2100

Novartis Investigative Site, Copenhagen

08950

Novartis Investigative Site, Esplugues de Llobregat. Barcelona

SM2 5PT

Novartis Investigative Site, Sutton

WC1N 3JH

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY