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

Status: Recruiting

Phase:

NCT ID: NCT02684058 (View complete trial on ClinicalTrials.gov)

DFCI Protocol ID: 17-532

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 relapsed or refractory high grade glioma.

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:

Mark Kieran, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

  -  Diagnosis of High Grade glioma

  -  Relapsed, progressed or failed to respond to frontline therapy.

  -  Able to swallow capsules

Exclusion Criteria:

  -  Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK
     inhibitor

  -  Cancer treatment within the past 3 weeks

  -  Stem cell transplant within the past 3 months

  -  History of heart disease

  -  Pregnant or lactating females

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