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NCT06188741 · ClinicalTrials.gov registry record · Phase 2
Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1
A Phase 2 study of Neurofibromatosis 1 and Plexiform Neurofibroma, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 13
- Study locations
NCT06188741: Recruiting Phase 2 study of Neurofibromatosis 1 and Plexiform Neurofibroma, sponsored by University of Alabama at Birmingham.
NCT06188741 is a Phase 2 study of Neurofibromatosis 1 and Plexiform Neurofibroma that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 200 participants, below the 1,027-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (81% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06188741, a Phase 2 study of Neurofibromatosis 1 and Plexiform Neurofibroma, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 13
- Study locations
Study Summary
Plexiform neurofibromas (PN) are known to cause significant morbidity in children with NF1. The recent FDA approval for selumetinib in children 2 years and older with inoperable symptomatic PN was based on the finding that selumetinib shrinks the majority of PN in children with NF1 and results in clinically meaningful benefit such as improvement in pain or range of motion. However, many morbidities, such as blindness or nerve damage, cannot be fully reversed with PN shrinkage. Therefore, there remains a critical need in this patient population to determine if young participants with PN in high-risk locations may benefit from early medical intervention prior to the development of clinical problems. This study will determine whether participants with asymptomatic PN in high-risk locations can potentially benefit from early treatment with selumetinib.
Primary Outcome
Progression free survival (PFS) in the group treated with selumetinib compared to those in the observation group
Conditions Studied
Interventions
- DRUG Selumetinib
Study Locations (13)
Illinois
- Lurie Children's Hospital of Chicago - Chicago
- University of Chicago - Chicago
Maryland
- Johns Hopkins University - Baltimore
- National Cancer Institute/ National Institutes of Health - Bethesda
Alabama
- Childrens of Alabama - Birmingham
California
- Children's Hospital of Los Angeles - Los Angeles
District of Columbia
- Children's National Hospital - Washington D.C.
Indiana
- Riley Hospital for Children/Indiana University - Indianapolis
Massachusetts
- Boston Children's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-08-27 |
| Est. Completion | 2032-09-01 |
| Phase | Phase 2 |
What NCT06188741 shows while recruiting
NCT06188741 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,027-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 1 intervention - of which Selumetinib is the first listed.
NCT06188741 lists 13 locations in 11 states (Illinois, Maryland, Alabama).
Frequently Asked Questions
What is clinical trial NCT06188741 about?
NCT06188741 is a clinical study titled "Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1". Plexiform neurofibromas (PN) are known to cause significant morbidity in children with NF1. The recent FDA approval for selumetinib in children 2 years and older with inoperable symptomatic PN was based on the finding that selumetinib shrinks the majority of PN in children with NF1 and results in cl...
What is the current status of trial NCT06188741?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2025-08-27. Estimated completion is 2032-09-01.
What conditions does trial NCT06188741 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Plexiform Neurofibroma.
What interventions are being tested in trial NCT06188741?
The interventions under investigation include: Selumetinib (DRUG).
Who is sponsoring clinical trial NCT06188741?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06188741 being conducted?
This trial has 13 study locations across Alabama, California, District of Columbia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06188741's enrollment target sits among peer trials
200 8th of 24 higher than 17 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.
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