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)
Michael Ferguson, MD
Primary Investigator
Brief description of study
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Low Grade Glioma,High Grade Glioma,BRAF mutation,Low Grade Glioma (LGG),relapsed or refractory High Grade Glioma (HGG), Astrocytoma, Oligodenroglioma, Glioblastoma, Zanthiastrocytoma, Glioma, Gangliocytoma, Neurocytoma, Iponeurocytoma, Papillary Glioneuronal Tumor, Rosette-forming Glioneurona Tumor
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Age: Between 1 Years - 17 Years
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Gender: All
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
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