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Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG and LGG

Trial Status: Active

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.

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

Colorado

Aurora
Children's Hospital Colorado
Status: ACTIVE

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: ACTIVE

Indiana

Indianapolis
Riley Hospital for Children
Status: ACTIVE
Contact: Anne Bubnick
Phone: 317-948-0101

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Lianne Greenspan
Phone: 617-632-3352

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Tennessee

Memphis
Saint Jude Children's Research Hospital
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
Texas Children's Hospital
Status: ACTIVE

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Novartis Pharmaceuticals Corporation

  • Primary ID CDRB436G2201
  • Secondary IDs NCI-2018-00387, 2015-004015-20
  • Clinicaltrials.gov ID NCT02684058