Clinical Trial

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

Study acronym: ReNeu
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Trial sites reduced: 50 -> 43 locations 2026-07-11
notable Sponsor changed: SpringWorks Therapeutics, Inc. -> SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany 2026-05-07
Trial Details
NCT Number NCT03962543
Lead Sponsor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Conditions Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1)
Enrollment 114 participants
Start Date 2019-09-29
Primary Completion 2023-09-20 (estimated)
Study Completion 2028-12-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-10