Trials / Completed
CompletedNCT04495127
Selumetinib Paediatric NF1 Japan Study
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)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 3 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selumetinib | Selumetinib 25 mg/m2 BID |
Timeline
- Start date
- 2020-08-31
- Primary completion
- 2021-06-16
- Completion
- 2023-03-24
- First posted
- 2020-07-31
- Last updated
- 2023-04-26
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04495127. Inclusion in this directory is not an endorsement.