A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 16, 2020

Primary Completion Date

August 16, 2022

Study Completion Date

August 31, 2026

Conditions
Neurofibromatosis 1Neurofibroma Plexiform
Interventions
DRUG

Selumetinib

"All eligible subjects will first receive a single oral dose of selumetinib 25 mg/m\^2. After a washout period of 2 days, oral selumetinib 25 mg/m\^2 twice daily will be administered continuously. Subjects will continue to receive selumetinib until disease progression or unacceptable drug-related toxicity, whichever occurs first.~10 mg and 25 mg capsules strengths available."

Trial Locations (2)

200011

Research Site, Shanghai

CN-200092

Research Site, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY