Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 12 Months and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Other protocol-defined Inclusion/exclusion may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
HGG cohort: Dabrafenib and trametinib
HGG cohort: All patients in the HGG cohort will receive DRB+TMT
  • Drug: dabrafenib
    dabrafenib oral, twice daily.
    Other names:
    • DRB436
  • Drug: trametinib
    trametinib oral, once daily.
    Other names:
    • TMT212
Active Comparator
LGG cohort: Carboplatin with vincristine
LGG cohort: Patients randomized 2:1 to either DRB+TMT or active comparator chemotherapy.
  • Drug: Carboplatin with vincristine
    Chemotherapy of carboplatin with vincristine - LGG only
Experimental
LGG cohort: Dabrafenib and trametinib
LGG cohort: Patients randomized 2:1 to either DRB+TMT or active comparator chemotherapy.
  • Drug: dabrafenib
    dabrafenib oral, twice daily.
    Other names:
    • DRB436
  • Drug: trametinib
    trametinib oral, once daily.
    Other names:
    • TMT212

Recruiting Locations

Children's National and nearby locations

Children s National Hospital
Washington, District of Columbia 20010
Contact:
Sabrina Malik
202-884-2120
samalik@childrensnational.org

More Details

NCT ID
NCT02684058
Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.