At a glance
ClinicalIndex Comparison RecordPhase 2Active· 114 enrolled
Drug / intervention
Mirdametinib (PD-0325901) oral capsule or dispersible tabletdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients With Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) That Are Causing Significant Morbidity
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany·interventional·Posted May 24, 2019·Updated May 6, 2026
In Brief
A Phase 2 clinical trial evaluating Mirdametinib (PD-0325901) oral capsule or dispersible tablet for Plexiform Neurofibroma and Neurofibromatosis Type 1 (NF1). Active but no longer recruiting, targeting 114 participants across 50 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2Active
2020202120222023202420252026202720282029
First PostedMay 2019
Enrollment StartSep 2019
Primary CompletionSep 2023
TodayJul 2026
Study CompletionDec 2028
First PostedMay 24, 2019
Enrollment StartSep 29, 2019
Primary CompletionSep 20, 2023
Study CompletionDec 22, 2028
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.1 years ago
Interventions
Mirdametinib (PD-0325901) oral capsule or dispersible tabletdrug
Mirdametinib (PD-0325901) capsule or dispersible tablet