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

NCT05891847

TerminatedN/A

Sponsor: AstraZeneca

Conditions: Neurofibroma

Countries: 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

Eligibility overview

Sex: ALL

Age: 3 Years to 18 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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 the study or started the therapy at the age of 18 years old),
* Patients whose parents or guardians have signed a consent form.

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 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.
Locations (5)
  • Moscow, Moscow, Russia
  • Moscow, Russia
  • Novosibirsk, Russia
  • Saint Petersburg, Russia
  • Yekaterinburg, Russia