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MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

NCT03962543 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-05-06

Study results available
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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

  • Plexiform Neurofibroma
  • Neurofibromatosis Type 1 (NF1)

Interventions

DRUG

Mirdametinib (PD-0325901) oral capsule or dispersible tablet

Mirdametinib (PD-0325901) capsule or dispersible tablet

Sponsors & Collaborators

  • SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Christopher L Moertel, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-29
Primary Completion
2023-09-20
Completion
2028-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03962543 on ClinicalTrials.gov