Population Pharmacokinetic Analysis of Selumetinib and Its N-desmethyl Metabolite in Japanese and Non-Japanese Pediatric Patients with Neurofibromatosis Type 1 and Inoperable Plexiform Neurofibromas

Table 1

Pooled clinical trials in pediatric patients with NF1 with inoperable PN.

Clinical trial description	Dose (mg/m^2; twice daily)	PK sampling
D1532C00057 (SPRINT) phase I	20, 25, 30	Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 5, 8, 10–12, 24, and 30–36 h postdose
		Cycle 1 day 28: predose
D1532C00057 (SPRINT) phase II stratum 1	25	Cycle 1 Day 1: predose, 0.5, 1.5, 3, 6, and 10–12 h postdose
		Cycle 1 Day 28: predose, 0.5, 1.5, 3, and 6 h postdose
D1346C00013 (Japan phase I)	25	Cycle 1 Day 1: predose, 0.5, 1.5, 3, 6, and 10–12 h postdose
		Cycle 2 Day 1: predose, 0.5, 1.5, 3, and 6 h postdose

One cycle was 28 days. NF1, neurofibromatosis type 1; PK, pharmacokinetic; PN, plexiform neurofibromas.