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)
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.
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.
Giant Cell Astrocytoma
Anaplastic Pleomorphic Xanthoastrocytoma
Chordoid Glioma of Third Ventricle
Dysplastic Gangliocytoma of Cerebrellum
Desmoplastic Infantile Astrocytoma and Ganglioglioma
Papillary Glioneuronal Tumor
Rosette-forming Glioneurona Tumor
Dec 28, 2017
Oct 16, 2025
12 Years - 17 Years (Child)
dabrafenib oral, twice daily.
trametinib oral, once daily.
Carboplatin with vincristine
Chemotherapy of carboplatin with vincristine - LGG only
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
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.
Phoenix Childrens Hospital
Children's Hospital of Orange County
Childrens Hospital Colorado
Children s National Hospital
District of Columbia
Nemours Children's Clinic Division of Endocrinology
Nicklaus Children s Hospital
Ann and Robert H Lurie Childrens Hospital of Chicago
Indiana University School of Medicine
Johns Hopkins University IDS Pharmacy John Hopkins Hospital
Dana Farber Cancer Institute
Children s Mercy Hospital
Kansas City, 64108
Washington University School of Medicine SC
Saint Louis, 63110
Memorial Sloan Kettering Cancer Center PC-2
New York, 10065
Cincinnati Children's Hospital Medical Center Cancer & Blood Disease Inst.
Children's Hospital of Pittsburgh of UPMC
St Jude Children's Research Hospital
UT Southwestern Medical Center UTSW/Children's Medical Center
Texas Children s Hospital Baylor College of Medicine