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)

Recruiting
1 years - 17 years
All
Phase N/A
1 Location

Brief description of study

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.

Detailed description of study

The purpose of this clinical research study is to find out if the drugs dabrafenib and trametinib are safe and beneficial in people with BRAF mutation positive LGG or relapsed or refractory BRAF mutation positive HGG.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Zanthiastrocytoma,Rosette-forming Glioneurona Tumor,Glioma,Astrocytoma,Iponeurocytoma,Gangliocytoma,High Grade Glioma,Glioblastoma,BRAF mutation,Papillary Glioneuronal Tumor,Oligodenroglioma,Low Grade Glioma,Neurocytoma
  • Age: 1 years - 17 years
  • 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

Updated on 04 Aug 2024. Study ID: 1803872717 (PHO-FERG-NOVARTIS-36G2201)

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