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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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