Study identifier:D1346C00011
ClinicalTrials.gov identifier:NCT04590235
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Neurofibromatosis 1
Phase 1
No
Selumetinib
All
32
Interventional
3 Years - 99 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
Merck Sharp & Dohme Corp.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Selumetinib All eligible subjects will first receive a single oral dose of selumetinib 25 mg/m^2. Then, selumetinib 25 mg/m^2 oral twice daily will be administered continuously until disease progression or unacceptable drug-related toxicity, whichever occurs first. | - |