Last updated on May 2020

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

Are you eligible to participate in this study?

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

  • Conditions: Malignant neoplasm of brain | Pleomorphic Xanthoastrocytoma | Rosette-forming Glioneurona Tumor | Giant Cell Astrocytoma | Glioblastoma Multiforme | Chordoid Glioma of Third Ventricle | Glioma | Ganglioglioma | Anaplastic Pleomorphic Xanthoastrocytoma | Ganglioneuroma | Papillary Glioneuronal Tumor | Astrocytoma | Brain Cancer | Desmoplastic Infantile Astrocytoma and Ganglioglioma | Extraventricular Neurocytoma | Anaplastic Ganglioglioma | Dysplastic Gangliocytoma of Cerebrellum | Cerebellar Iponeurocytoma | Oligodendroglioma | Brain Tumor | Gliomas | Neurocytoma | Angiocentric Glioma | Brain Tumor (Pediatric)
  • Age: Between 1 - 17 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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