Trial purpose
Cancer treatment
Tumor type
Brain and Spinal
Age
1 - 17
Clinical summary
Summary
This is a non-randomised trial. Participants will be allocated to one of three cohorts. In the HGG cohort, all patients will receive dabrafenib (DRB) and trametinib (TMT) oral, twice daily. In the LGG cohorts patients will be randomised 2:1 to either DRB+TMT or active chemotherapy.
Conditions
This trial is treating people with glioma
Eligibility
Inclusion
- Diagnosis of BRAF V600 mutant High Grade glioma that had 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
- 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
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Novartis Pharmaceuticals
Scientific Title
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)
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