PASS of Paediatric Patients Initiating Selumetinib
← catalyst calendarNCT05388370 · readout in 642 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
124actual
Sites
46
Countries
Austria, France, Germany +7
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 | 2022-05-23 | actual | When the study began enrolling |
| Primary completion | 2028-05-23 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-05-23 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-12 | 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
Primary outcomes
what the primary-completion date above is the date OFLVEF reduction
measured at routine clinical care throughout the follow up, with frequency of 6 to 12 months
Occurrence of Physeal dysplasia after treatment start
measured at routine clinical care throughout the follow up, with frequency of 6 to 12 months
Rise of serum creatine phosphokinase levels AND concurrent musculoskeletal symptoms
measured at routine clinical care throughout the follow up, with frequency of 6 to 12 months, up to 6 years
Rise in transaminase (ALT and AST) and concurrent rise in bilirubin
measured at routine clinical care throughout the follow up, with frequency of 6 to 12 months, up to 6 years
Cumulative incidence of ocular toxicity
measured at routine clinical care throughout the follow up, with frequency of 6 to 12 months
Cumulative incidence of Abnormal pubertal development
measured at routine clinical care throughout the follow up, with frequency of 6 to 12 months
Publications
- PMID 40704003 — cited as background
- PMID 17868186 — cited as background
- PMID 18064739 — cited as background
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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