Brain Tumours

Children or adolescents with BRAF V600-mutant solid tumors

COMPLETED

Dabrafenib dose escalation (modified rolling 6 design)

• MTD • RP2D • Exposure consistent with adult dose*

Eligible patient with solid tumors

3.75 mg/kg

4.5 mg/kg

3.0 mg/kg

5.25 mg/kg

Phase 1 escalation Phase 2 expansion cohorts

ONGOING

HGG (n = 10)

Dabrafenib • RP2D • PK • Safety, tolerability • Preliminary antitumor activity

Low grade glioma (LGG) (n = 10)

LCH (n = 10)

Other solid tumors (eg, PTC, melanoma) (n = 10)

Key inclusion criteria

Key exclusion criteria

• Recurrent, refractory, or progressive disease after at least 1 standard therapy o (metastatic melanoma may be first line) • BRAF V600 mutation positive o (local test with central confirmation)

• Prior treatment with dabrafenib, other RAF or MEK inhibitor (part 2 only) • Other malignancy

RP2D, recommended phase 2 dose. *AUC (0-12) = 4,000-5,500 ng • h/mL.

Registered at clinicaltrials.gov as NCT01677741

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