Brain Tumours

Methods

• V600 mutation status established locally; central confirmation available • Dabrafenib given orally twice daily, starting dose of 3.0 mg/kg/day – Formulations HPMC capsules (10, 25, 50, 75 mg strengths) and powder for suspension in water • Toxicity, pharmacokinetics, and response assessed at each dose level for patients aged ≥12 months to ≤12 years and >12 years • During assessment of filled dose level, enrollment allowed into lower tolerable dose levels (backfill) • Therapy to continue as long as patient is benefitting • Intrapatient dose escalation permitted

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