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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 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 45 participants.
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.
Interventions
- DRUG Binimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2024-04-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03231306
The ClinicalTrials.gov registry entry for NCT03231306 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Binimetinib is the first listed.
NCT03231306 reports 0 study locations.
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.
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