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Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas
Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

NCT04924608

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Neurofibromatosis 1, Plexiform Neurofibroma (PN)

Interventions: Selumetinib, Placebo

Countries: United States, Australia, Brazil, Canada, China, France, Germany, Italy

A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Adults ≥ 18 years at enrollment with diagnosis of NF1 with symptomatic, inoperable PN
* At least one inoperable target PN measurable by volumetric MRI analysis
* Chronic target PN pain score documented for minimum period during screening period
* Stable chronic PN pain medication use at enrollment
* Adequate organ and marrow function

Key Exclusion Criteria:

* Confirmed or suspected malignant glioma or MPNST (low grade glioma, including optic glioma not requiring systemic therapy or radiation therapy are exempt from this exclusion)
* History of malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence
* Clinically significant cardiovascular disease, including inherited coronary disease, acute coronary syndrome within 6 months prior to enrollment, uncontrolled angina, symptomatic heart failure, cardiomyopathy, severe valvular heart disease, abnormal LVEF and uncontrolled hypertension
* Ophthalmological findings/conditions including intraocular pressure \> 21 mmHg, RPED/CSR or RVO
* Prior exposure to MEK inhibitors
Locations (34)
  • Gainesville, Florida, United States
  • Rockville, Maryland, United States
  • St Louis, Missouri, United States
  • Commack, New York, United States
  • Melbourne, Australia
  • St Leonards, Australia
  • Porto Alegre, Brazil
  • Ribeirão Preto, Brazil
  • São Paulo, Brazil
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Beijing, China
  • Beijing, China
  • Guangzhou, China
  • Shenyang, China
  • Créteil, France
  • Lyon, France
  • Toulouse, France
  • Hamburg, Germany
  • Tübingen, Germany
  • Würzburg, Germany
  • Milan, Italy
  • Naples, Italy
  • Roma, Italy
  • Minatoku, Japan
  • Nagoya, Japan
  • Shinjuku-ku, Japan
  • Bydgoszcz, Poland
  • Moscow, Russia
  • Moscow, Russia
  • + 4 more on CT.gov