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

Study identifier:D1346C00011

ClinicalTrials.gov identifier:NCT04590235

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

Neurofibromatosis 1

Phase

Phase 1

Healthy volunteers

No

Study drug

Selumetinib

Sex

All

Actual Enrollment

32

Study type

Interventional

Age

3 Years - 99 Years

Date

Study Start Date: 16 Dec 2020
Primary Completion Date: 16 Aug 2022
Estimated Study Completion Date: 31 Aug 2026

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Merck Sharp & Dohme Corp.

Inclusion and exclusion criteria