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NCT04924608 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas
A Phase 3 study of Neurofibromatosis 1 and Plexiform Neurofibroma (PN), sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
- 20
- Study locations
NCT04924608: Active Phase 3 study of Neurofibromatosis 1 and Plexiform Neurofibroma (PN), sponsored by AstraZeneca.
NCT04924608 is a Phase 3 study of Neurofibromatosis 1 and Plexiform Neurofibroma (PN) that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 145 participants, below the 1,029-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04924608, a Phase 3 study of Neurofibromatosis 1 and Plexiform Neurofibroma (PN), is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
- 20
- Study locations
Study Summary
A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.
Primary Outcome
Objective response rate is defined as the proportion of participants who have a confirmed CR (defined as disappearance of the target PN, confirmed by a consecutive scan within 3 to 6 months after the first response) or confirmed PR (defined as a target PN volume decrease ≥ 20%, compared to baseline, confirmed by a consecutive scan within 3 to 6 months after the first response) by end of Cycle 16 as determined by ICR per REiNS criteria. Increase in the volume of the target PN by 20% or more comp
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Selumetinib
Study Locations (20)
Other
- Research Site - Melbourne
- Research Site - St Leonards
- Research Site - Porto Alegre
- Research Site - Ribeirão Preto
- Research Site - São Paulo
- Research Site - Beijing
- Research Site - Beijing
- Research Site - Guangzhou
- Research Site - Shenyang
- Research Site - Créteil
- Research Site - Lyon
- Research Site - Toulouse
- Research Site - Hamburg
- Research Site - Tübingen
Florida
- Research Site - Gainesville
Maryland
- Research Site - Rockville
Missouri
- Research Site - St Louis
New York
- Research Site - Commack
Ontario
- Research Site - Toronto
Quebec
- Research Site - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-11-19 |
| Est. Completion | 2029-02-15 |
| Phase | Phase 3 |
What the registry record for NCT04924608 still lists
NCT04924608 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 1,029-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04924608 names 20 study sites across 7 states, led by Other, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT04924608 about?
NCT04924608 is a clinical study titled "Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas". A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.
What is the current status of trial NCT04924608?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2021-11-19. Estimated completion is 2029-02-15.
What conditions does trial NCT04924608 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Plexiform Neurofibroma (PN).
What interventions are being tested in trial NCT04924608?
The interventions under investigation include: Placebo (OTHER), Selumetinib (DRUG).
Who is sponsoring clinical trial NCT04924608?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04924608 being conducted?
This trial has 20 study locations across Florida, Maryland, Missouri, New York, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neurofibromatosis 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04924608's enrollment target sits among peer trials
145 11th of 24 higher than 14 of 24 other Neurofibromatosis 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1
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