Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
Completed · Phase 2
Conditions studied: Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood, Anaplastic Oligodendroglioma, Glioblastoma, Pilocytic Astrocytoma, Giant Cell Astrocytoma, Pleomorphic Xanthoastrocytoma, Anaplastic Pleomorphic Xanthoastrocytoma, Angiocentric Glioma, Chordoid Glioma of Third Ventricle, Gangliocytoma, Ganglioglioma, Anaplastic Ganglioglioma, Dysplastic Gangliocytoma of Cerebrellum, Desmoplastic Infantile Astrocytoma and Ganglioglioma, Papillary Glioneuronal Tumor, Rosette-forming Glioneurona Tumor, Central Neurocytoma, Extraventricular Neurocytoma, Cerebellar Iponeurocytoma
In brief
The purpose of this study was to investigate the activity 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)
Key facts
- Study ID
- NCT02684058
- Run by
- Novartis Pharmaceuticals
- People needed
- 151
- Starts
- 2017-12-28
- Expected to finish
- 2023-04-28
- Last updated by the study team
- 2023-12-13
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Childrens National Hospital — Washington D.C., District of Columbia, United States
- Nicklaus Childrens Hospital — Miami, Florida, United States
- Ann and Robert H Lurie Childrens Hospital of Chicago . — Chicago, Illinois, United States
- Indiana University School of Medicine . — Indianapolis, Indiana, United States
- Johns Hopkins University IDS Pharmacy John Hopkins Hospital — Baltimore, Maryland, United States
- Washington University School of Medicine SC — St Louis, Missouri, United States
- Cincinnati Childrens Hospital Medical Center Cancer & Blood Disease Inst. — Cincinnati, Ohio, United States
- St Jude Children's Research Hospital — Memphis, Tennessee, United States
- Texas Children s Hospital Baylor College of Medicine — Houston, Texas, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Randwick, New South Wales, Australia
- Novartis Investigative Site — Parkville, Victoria, Australia
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Barretos, São Paulo, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — Vancouver, British Columbia, Canada
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Brno, Czechia
- Novartis Investigative Site — Prague, Czechia
- Novartis Investigative Site — Copenhagen, Denmark
- Novartis Investigative Site — Tampere, Finland
- Novartis Investigative Site — Lille, France
- Children's Hospital of Orange County — Orange, California, United States
Full record on ClinicalTrials.gov
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