A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
32actual
Sites
2
Country
China
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 | 2020-12-16 | actual | When the study began enrolling |
| Primary completion | 2022-08-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-08-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-10-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Neurofibromatosis 1
- Neurofibroma Plexiform
Intervention
- Drug: Selumetinib — also filed as Koselugo
Primary outcomes
what the primary-completion date above is the date OFAdverse events
measured For paediatric cohort: from signing the informed consent form until up to 3 years after last subject dosed; For adult cohort: from signing the informed consent form until up to 2 years+30 days after last subject dosed.
Area under the concentration-time curve from zero to the last measurable concentration (AUC0-t) of selumetinib and its metabolite (N-desmethyl selumetinib) in Chinese paediatric and adult subjects with NF 1 and inoperable Plexiform Neurofibromas
measured From the first consent patient first dose to last patient steady state PK collection. Expected duration is approximately 1 year.
Maximum plasma concentration (Cmax) of selumetinib and its metabolite (N-desmethyl selumetinib) in Chinese paediatric and adult subjects with NF 1 and inoperable Plexiform Neurofibromas
measured From the first consent patient first dose to last patient steady state PK collection. Expected duration is approximately 1 year.
Terminal half-life (t1/2) of selumetinib and its metabolite (N-desmethyl selumetinib) in Chinese paediatric and adult subjects with NF 1 and inoperable Plexiform Neurofibromas
measured From the first consent patient first dose to last patient steady state PK collection. Expected duration is approximately 1 year.
Publications
- PMID 42394972 — 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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