Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 21, 2021

Primary Completion Date

April 6, 2022

Study Completion Date

January 12, 2026

Conditions
Neurofibromatosis Type 1
Interventions
DRUG

Selumetinib

The dosing regimen for selumetinib (25 mg/m2 bid) will be based on BSA, during T1 and T2 the dose will be 25mg/m2, consistent with the approved prescribing information in the US. If T3 is required, appropriate dose of selumetinib will be defined by Data Review Committee for T3.

Trial Locations (9)

28009

Research Site, Madrid

44308

Research Site, Akron

55905

Research Site, Rochester

119620

Research Site, Moscow

125412

Research Site, Moscow

85-094

Research Site, Bydgoszcz

80-952

Research Site, Gdansk

02-091

Research Site, Warsaw

08950

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY