Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia
Reason given: 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.
Key facts
- Where
- Moscow, Novosibirsk, Saint Petersburg, and Yekaterinburg, RussiaSee the 4 sites
Where in Russia
- MoscowMoscow, RussiaNo longer taking part
- NovosibirskNovosibirsk, RussiaNo longer taking part
- Saint PetersburgSaint Petersburg, RussiaNo longer taking part
- YekaterinburgYekaterinburg, RussiaNo longer taking part
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT05891847
- Record updated
- 8 July 2026
- Original description
The purpose of this study is to evaluate the effectiveness, safety of selumetinib and patient's parameters of symptomatic inoperable PN NF1 in real clinical practice in RussiaRead full original descriptionShow less
Non-interventional Study of Patients With Plexiform Neurofibromas and Neurofibromatosis Type I Starting Selumetinib in Russia
The purpose of this study is to evaluate the effectiveness, safety of selumetinib and patient's parameters of symptomatic inoperable PN NF1 in real clinical practice in Russia
Inclusion: NF1 diagnosed (according to the criteria for evaluating NF1),; Symptomatic inoperable PN,; Patients receiving therapy with selumetinib. For newly treated patients - registration on the first day of starting treatment with selumetinib,; Age at starting of selumetinib treatment ≥ 3 to ≤ 18 years old (included in the study or started the therapy at the age of 18 years old),; Patients whose parents or guardians have signed a consent form.
Exclusion: Patients are excluded if there is evidence of an optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with chemotherapy or radiation therapy,; Patients who receive other antitumor treatment options on optic nerve glioma, malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer. If the patient on selumetinib treatment develop optic nerve glioma, malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer, he can continue selumetinib therapy +\- other treatment options on physician decision,; Female patients above 12 age who are pregnant /plan to become pregnant or at breast feeding; Patients currently participating in an interventional study/clinical trial,.