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

Last updated: June 9, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Warts

Brain Tumor

Treatment

N/A

Clinical Study ID

NCT05891847
D1340R00002
  • Ages 3-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 thestudy or started the therapy at the age of 18 years old),

  • Patients whose parents or guardians have signed a consent form.

Exclusion

Exclusion Criteria:

  • Patients currently participating in an interventional study/clinical trial,

  • Patients are excluded if there is evidence of an optic glioma, malignant glioma,malignant peripheral nerve sheath tumor, or other cancer, requiring treatment withchemotherapy 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, malignantglioma, malignant tumor of the peripheral nerve sheath, or other cancer, he cancontinue selumetinib therapy +- other treatment options on physician decision,

  • Female patients above 12 age who are pregnant /plan to become pregnant or at breastfeeding.

Study Design

Total Participants: 150
Study Start date:
March 21, 2023
Estimated Completion Date:
March 20, 2026

Study Description

This study will be non-interventional retrospective and prospective study. Assessment of parameters will be carried out as if a patient is treated in real-life clinical setting. The patients should be enrolled into this project after evaluation of eligibility criteria by an investigator 10 clinical sites. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Study population will consist of pediatric patients aged 3 years and older with NF1 and symptomatic inoperable PN who were prescribed with selumetinib

Connect with a study center

  • GBUZ Morozovskaya Children City Clinical Hospital DZM

    Moscow, Moskva 123112
    Russian Federation

    Site Not Available

  • GUZ MO Children Neuropsychiatric Hospital

    Moscow, Moskva 123112
    Russian Federation

    Active - Recruiting

  • Research Site

    Moscow, Moskva 123112
    Russian Federation

    Site Not Available

  • SMIC of children hematology, oncology and immunology n.a. D.Rogachev

    Moscow, Moskva 123112
    Russian Federation

    Site Not Available

  • Scientific institute of pediatrics n.a. Veltishchev

    Moscow, Moskva 123112
    Russian Federation

    Site Not Available

  • Research Site

    Ekaterinburg,
    Russian Federation

    Site Not Available

  • State Autonomous Healthcare Institution of the Sverdlovsk Region Regional Children Clinical Hospital

    Ekaterinburg,
    Russian Federation

    Site Not Available

  • Children Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan

    Kazan,
    Russian Federation

    Site Not Available

  • Novosibirsk State Medical University

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Research Site

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Almazov National Medical Research Centre

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Raisa Gorbacheva Memorial Institute of Children Hematology and Transplantation

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • St. Petersburg Clinical Scientific and Practical Center of Specialized Types of Medical Care

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Research Site

    Saint-Petersburg,
    Russian Federation

    Site Not Available

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