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NCT03231306 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT03231306: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT03231306 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03231306, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is a phase II open label study that will evaluate children ≥ 1 year of age and adults with neurofibromatosis type 1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor, binimetinib. The primary objective is to determine if there is an adequate level of disease responsiveness to binimetinib in children and adults with NF1 and inoperable plexiform neurofibromas. The objective response to binimetinib is defined as ≥ 20% decrease in tumor volume reduction by 12 courses.
Primary Outcome
To determine the objective response defined as 20% or greater tumor volume reduction. Patients will undergo volumetric assays of their target PN using MRI.
Interventions
- DRUG Binimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2024-04-17 |
| Phase | Phase 2 |
What the finished NCT03231306 record still lists
NCT03231306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 1 intervention - of which Binimetinib is the first listed.
NCT03231306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03231306 about?
NCT03231306 is a clinical study titled "Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas". This is a phase II open label study that will evaluate children ≥ 1 year of age and adults with neurofibromatosis type 1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor, binimetinib. The primary objective is to determine if there is an adequate level of disease responsiveness to bin...
What is the current status of trial NCT03231306?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2017-11-28. Estimated completion is 2024-04-17.
What interventions are being tested in trial NCT03231306?
The interventions under investigation include: Binimetinib (DRUG).
Who is sponsoring clinical trial NCT03231306?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03231306's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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