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

NCT04924608 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2026-03-23

Study results available
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Summary

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

Conditions

  • Neurofibromatosis 1
  • Plexiform Neurofibroma (PN)

Interventions

DRUG

Selumetinib

Selumetinib oral capsules (10 mg and 25 mg)

OTHER

Placebo

Placebo oral capsules for Selumetinib masking (10 mg and 25 mg)

Sponsors & Collaborators

Principal Investigators

  • Alice P. Chen, MD · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2024-08-05
Completion
2029-02-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04924608 on ClinicalTrials.gov