Selumetinib Paediatric NF1 Japan study

Study identifier:D1346C00013

ClinicalTrials.gov identifier:NCT04495127

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor, in Japanese Paediatric Subjects with Neurofibromatosis Type 1 (NF1) and Inoperable and Symptomatic Plexiform Neurofibromas (PN)

Medical condition

Neurofibromatosis Type 1

Phase

Phase 1

Healthy volunteers

No

Study drug

Selumetinib

Sex

All

Actual Enrollment

12

Study type

Interventional

Age

3 Years - 18 Years

Date

Study Start Date: 31 Aug 2020
Primary Completion Date: 16 Jun 2021
Study Completion Date: 24 Mar 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria