Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG and LGG

Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

ClinicalTrials.gov Identifier: NCT02684058

Novartis Reference Number: CDRB436G2201

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma or relapsed or refractory high grade glioma.

Condition 
Diffuse Astrocytoma
Anaplastic Astrocytoma
Astrocytoma
Oligodendroglioma, Childhood
Anaplastic Oligodendroglioma
Glioblastoma
Pilocytic Astrocytoma
Giant Cell Astrocytoma
Pleomorphic Xanthoastrocytoma
Anaplastic Pleomorphic Xanthoastrocytoma
Angiocentric Glioma
Chordoid Glioma of Third Ventricle
Gangliocytoma
Ganglioglioma
Anaplastic Ganglioglioma
Dysplastic Gangliocytoma of Cerebrellum
Desmoplastic Infantile Astrocytoma and Ganglioglioma
Papillary Glioneuronal Tumor
Rosette-forming Glioneurona Tumor
Central Neurocytoma
Extraventricular Neurocytoma
Cerebellar Iponeurocytoma
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
142 participants
Start date 
Dec 28, 2017
Completion date 
Oct 16, 2025
Gender 
All
Age(s)
12 Years - 17 Years (Child)

Interventions

Drug
dabrafenib
dabrafenib oral, twice daily.
Drug
trametinib
trametinib oral, once daily.
Drug
Carboplatin with vincristine
Chemotherapy of carboplatin with vincristine - LGG only

Eligibility Criteria

Inclusion Criteria:

Diagnosis of BRAF V600 mutant High Grade glioma that has relapsed, progressed or failed to respond to frontline therapy
Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following surgical excision, or non-surgical candidates with necessity to begin first systemic treatment because of a risk of neurological impairment with progression.
Confirmed measurable disease

Exclusion Criteria:

Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK inhibitor
HGG patient: Cancer treatment within the past 3 weeks. LGG patient: Any systemic therapy or radiotherapy prior to enrollment
LGG patients: history of allergic reaction or contraindications to the use of carboplatin or vincristine
Stem cell transplant within the past 3 months
History of heart disease
Pregnant or lactating females

Other protocol-defined Inclusion/exclusion may apply.

Study Locations

United States
Phoenix Childrens Hospital
Recruiting
Phoenix, 85016
Arizona
United States
Children's Hospital of Orange County
Recruiting
Orange, 92868
California
United States
Childrens Hospital Colorado
Recruiting
Aurora, 80045
Colorado
United States
Children s National Hospital
Recruiting
Washington, 20010
District of Columbia
United States
Nemours Children's Clinic Division of Endocrinology
Recruiting
Jacksonville, 32207
Florida
United States
Nicklaus Children s Hospital
Recruiting
Miami, 33155
Florida
United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Recruiting
Chicago, 60611
Illinois
United States
Indiana University School of Medicine
Recruiting
Indianapolis, 46202-2810
Indiana
United States
Johns Hopkins University IDS Pharmacy John Hopkins Hospital
Recruiting
Baltimore, 21287
Maryland
United States
Dana Farber Cancer Institute
Recruiting
Boston, 02215
Massachusetts
United States
Children s Mercy Hospital
Recruiting
Kansas City, 64108
Missouri
United States
Washington University School of Medicine SC
Recruiting
Saint Louis, 63110
Missouri
United States
Memorial Sloan Kettering Cancer Center PC-2
Recruiting
New York, 10065
New York
United States
Cincinnati Children's Hospital Medical Center Cancer & Blood Disease Inst.
Recruiting
Cincinnati, 45229-3039
Ohio
United States
Children's Hospital of Pittsburgh of UPMC
Recruiting
Pittsburgh, 15224
Pennsylvania
United States
St Jude Children's Research Hospital
Recruiting
Memphis, 38105
Tennessee
United States
UT Southwestern Medical Center UTSW/Children's Medical Center
Recruiting
Dallas, 75235
Texas
United States
Texas Children s Hospital Baylor College of Medicine
Recruiting
Houston, 77030
Texas
United States
Argentina
Novartis Investigative Site
Active, not recruiting
Caba, C1428AQK
Buenos Aires
Argentina
Australia
Novartis Investigative Site
Recruiting
Randwick, 2130
New South Wales
Australia
Novartis Investigative Site
Recruiting
Parkville, 3052
Victoria
Australia
Belgium
Novartis Investigative Site
Recruiting
Brussels, BE-B-1200
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Barretos, 14784 400
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 08270-070
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,
SP
Brazil
Canada
Novartis Investigative Site
Recruiting
Vancouver, V6H 3V4
British Colombia
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1X8
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1C5
Quebec
Canada
Novartis Investigative Site
Recruiting
Montreal, H4A 3J1
Quebec
Canada
Czechia
Novartis Investigative Site
Recruiting
Brno, 613 00
-
Czechia
Novartis Investigative Site
Recruiting
Praha 5, 150 06
-
Czechia
Denmark
Novartis Investigative Site
Recruiting
Copenhagen, 2100 O
-
Denmark
Finland
Novartis Investigative Site
Recruiting
Tampere, 33521
-
Finland
France
Novartis Investigative Site
Recruiting
France, 94800
Villejuif
France
Novartis Investigative Site
Recruiting
Angers Cedex 1, 49033
-
France
Novartis Investigative Site
Recruiting
Lille Cedex, 59020
-
France
Novartis Investigative Site
Recruiting
Lyon Cedex, 69373
-
France
Novartis Investigative Site
Recruiting
Marseille Cedex 5, 13385
-
France
Novartis Investigative Site
Recruiting
Paris, 75231
-
France
Novartis Investigative Site
Recruiting
Strasbourg Cedex, F 67098
-
France
Novartis Investigative Site
Recruiting
Toulouse Cedex 9, 31059
-
France
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86179
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20246
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Israel
Novartis Investigative Site
Recruiting
Petach-Tikva, 49202
-
Israel
Novartis Investigative Site
Recruiting
Tel-Hashomer, 52621
-
Israel
Italy
Novartis Investigative Site
Recruiting
Firenze, 50139
FI
Italy
Novartis Investigative Site
Recruiting
Genova, 16147
GE
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Roma, 00165
RM
Italy
Novartis Investigative Site
Recruiting
Torino, 10126
TO
Italy
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 157-8535
Tokyo
Japan
Novartis Investigative Site
Recruiting
Osaka, 534-0021
-
Japan
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3584
CS
Netherlands
Novartis Investigative Site
Withdrawn
Rotterdam, 3015 CE
-
Netherlands
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 117198
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28007
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
-
Spain
Sweden
Novartis Investigative Site
Recruiting
Stockholm, 17176
-
Sweden
Switzerland
Novartis Investigative Site
Recruiting
Zuerich, 8032
-
Switzerland
United Kingdom
Novartis Investigative Site
Recruiting
Leeds, LS1 3EX
-
United Kingdom
Novartis Investigative Site
Recruiting
Liverpool, L12 2AP
-
United Kingdom
Novartis Investigative Site
Recruiting
London, WC1N 3JH
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111

Have a question?

Call 1-999-669-6682 or email [email protected]