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Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia

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NCT05891847

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase
Status
Terminated
Study type
Observational
Enrollment
150actual
Sites
5
Country
Russia

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

Why the sponsor stopped it

Statistically significant failure to achieve key secondary endpoints. The current data do not demonstrate sufficient potential to achieve the planned scientific objectives. The need to optimize the allocation of company resources.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-03-21actualWhen the study began enrolling
Primary completion2025-07-11actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-07-11actualThe whole study's end, after follow-up
First posted2023-06-07actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-08actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Neurofibroma

Primary outcomes

what the primary-completion date above is the date OF
ORR in patients receiving selumetinib according to REiNS criteria
measured from the FSI date (21 Mar 2023) till 36 months from FSI
Best objective response on selumetinib treatment
measured from the FSI date (21 Mar 2023) till 36 months from FSI
Time to discontinuation of selumetinib
measured from the FSI date (21 Mar 2023) till 36 months from FSI
Description of diagnostic algorithms for PN NF1 in Russia
measured from the FSI date (21 Mar 2023) till 36 months from FSI
Reasons for discontinuation of selumetinib
measured from the FSI date (21 Mar 2023) till 36 months from FSI

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