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| Diagnosis | Low Grade Glioma, relapsed or refractory high grade glioma with BRAF V600 mutation | Study Status | Closed to enrollment |
| Phase | II |
| Age | Child - (12 Months to 17 Years) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Dabrafenib and trametinib (oral).
Other drugs are given as usually administered for low grade glioma therapy. |
| Last Posted Update | 2022-04-25 |
| ClinicalTrials.gov # | NCT02684058 |
International Sponsor
Novartis PharmaceuticalsPrincipal Investigators for Canadian Sites
BC Children’s Hospital – Dr. Juliette Hukin
The Hospital for Sick Children - Dr. Uri Tabori
Montreal Children's Hospital – Dr. Catherine Vézina
CHU Ste-Justine – Dr. Sébastien Perreault
Centres
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
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.
Primary outcome measures are as below
- High Grade Glioma cohort: Overall response rate as determined by central independent assessment based on MRI or CTscans using Response Assessment in Neuro-Oncology Criteria (RANO) criteria.
- Low Grade Gioma : Overall response rate as determined by blinded central independent assessment based on MRI or CT scans using RANO criteria.
In the Low Grade Glioma cohort, patients are randomized 2:1 to either dabrafenib + trametinib or active comparator chemotherapy with vincristine and carboplatin.
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
