A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Tolerability and Pharmacokinetics of Selumetinib after Multiple Doses in Adolescent Children with Neurofibromatosis Type 1 Related Plexiform Neurofibromas
Neurofibromatosis Type 1
12 Years - 17 Years
Endpoint Classification: -
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Verified 01 Jul 2023 by AstraZeneca
Merck Sharp & Dohme Corp.
No locations available
|Experimental: selumetinib single arm|
This is a sequential study consisting of a screening period lasting up to 28 days, a 28 day (1 cycle) treatment period (T1) in a fed state, a 7 day washout period, a further 1 cycle treatment period (T2) in a fasted state and an extension to T2 until results from the primary analysis are available. During Treatment Period 1 and 2 all participants will receive selumetinib (25 mg/m2 bid). If a third treatment period (T3) is required, participants will enter a 7 day washout period followed by a treatment period in a fed state at an adjusted dose for 3 cycles.