Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
NCT03962543 · View on ClinicalTrials.gov ↗
Study Summary
This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901). Eligible participants may continue in a long-term follow-up phase.
Conditions Studied
Interventions
- DRUG Mirdametinib (PD-0325901) oral capsule or dispersible tablet
Study Locations (20)
California
- Children's Hospital Los Angeles — Los Angeles
- UCLA Oncology Center — Los Angeles
- University of California - Irvine Health — Orange
- Children's Hospital of Orange County — Orange
- Lucile Packard Children's Hospital Stanford — Palo Alto
- University of California - Davis Comprehensive Cancer Center — Sacramento
Florida
- University of Florida Clinical Research Center — Gainesville
- Nicklaus Children's Hospital — Miami
- AdventHealth Pediatric Oncology Hematology at Orlando — Orlando
- Orlando Health, Inc. — Orlando
- Johns Hopkins All Children's Hospital — St. Petersburg
- Moffitt Cancer Center — Tampa
Alabama
- University of Alabama at Birmingham/Children's of Alabama — Birmingham
Arizona
- Mayo Clinic Hospital — Phoenix
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- Children's Hospital Colorado — Aurora
Delaware
- Nemours A. I. duPont Hospital for Children — Wilmington
District of Columbia
- Children's National Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2019-09-29 |
| Est. Completion | 2028-12-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03962543
The ClinicalTrials.gov registry entry for NCT03962543 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SpringWorks Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Plexiform Neurofibroma appearing as the primary indexed condition, and to 1 intervention — of which Mirdametinib (PD-0325901) oral capsule or dispersible tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03962543 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03962543 about?
NCT03962543 is a clinical study titled "MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas". This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901). Eligible participants may continue in a long-term follow-up phase.
What is the current status of trial NCT03962543?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2019-09-29. Estimated completion is 2028-12-22.
What conditions does trial NCT03962543 study?
This clinical trial studies the following conditions: Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03962543?
The interventions under investigation include: Mirdametinib (PD-0325901) oral capsule or dispersible tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03962543?
This trial is sponsored by SpringWorks Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03962543 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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