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drugset / Trial / NCT03975829

Pediatric Long-Term Follow-up and Rollover Study

NCT03975829 ↗

Phase 4 Active not recruiting 163 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.

Timeline

Start
2019-11-04
Primary completion
2026-11-05
Completion
2026-11-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabrafenib Small molecule — Oral
Subject Trametinib Small molecule — Oral

Indications

Lhermitte-Duclos disease anaplastic astrocytoma anaplastic ganglioglioma anaplastic oligodendroglioma anaplastic pleomorphic xanthoastrocytoma angiocentric glioma central neurocytoma cerebellar liponeurocytoma childhood oligodendroglioma chordoid glioma of the third ventricle desmoplastic infantile astrocytoma/ganglioglioma diffuse astrocytoma extraventricular neurocytoma gangliocytoma glioblastoma neurofibromatosis type 1 papillary glioneuronal tumor pilocytic astrocytoma pleomorphic xanthoastrocytoma rosette-forming glioneuronal tumor of fourth ventricule