Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN
← catalyst calendarNCT05309668 · results posted · readout in 468 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
36actual
Sites
16
Countries
Germany, Italy, Japan +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-21 | actual | When the study began enrolling |
| Primary completion | 2027-11-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-04-28 | estimated | The whole study's end, after follow-up |
| First posted | 2022-04-04 | actual | When this record first appeared on the registry |
| Results posted | 2025-05-14 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Neurofibromatosis Type 1
Interventions
- Drug: Selumetinib granule formulation
- Drug: Selumetinib capsule formulation
Primary outcomes
what the primary-completion date above is the date OFSelumetinib AUC0-12 Derived After Single Dose Administration
measured Pre-dose and 1, 2, 3, 4, 6, 8 and 10-12 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)
Adverse Events Graded by CTCAE Ver 5.0
measured from screening until 30 days after last dose
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-03-15 · 10.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-04-29 · 12.9 MB · SAP_001.pdf
Publications
- PMID 41592259 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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