Selumetinib Paediatric NF1 Japan Study

Sponsor
AstraZeneca
Study ID
NCT04495127
Phase
PHASE1
Status
Completed

Conditions

  • Neurofibromatosis Type 1

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase I open label study designed to evaluate the safety, tolerability, PK and efficacy of selumetinib in Japanese paediatric patients with neurofibromatosis type 1 and inoperable and symptomatic plexiform neurofibroma.

Key Dates

Start date
Aug 31, 2020
Status verified
Apr 2023
Primary completion
Jun 16, 2021
Completion
Mar 24, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selumetinib

Primary Outcome Measure

Safety and tolerability in terms of adverse events [ Time Frame: From obtaining the first informed consent until 30 days after the last dose (Selumetinib). Expected duration is approximately 2 years. ]

Related Studies