Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia
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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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-03-21 | actual | When the study began enrolling |
| Primary completion | 2025-07-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-11 | actual | The whole study's end, after follow-up |
| First posted | 2023-06-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-08 | actual | The 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 OFORR 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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