Phase 2Active, not recruiting
MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas (ReNeu)
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
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany (Industry)
- Enrollment
- 114 enrolled
- Conditions
- Plexiform Neurofibroma; Neurofibromatosis Type 1 (NF1)
- Interventions
- Mirdametinib (PD-0325901) oral capsule or dispersible tablet
- Ages
- children, adults, older adults
- Registry
- NCT03962543
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Confirmed Objective Response Rate at the End of the Treatment Phase.
History
Study completion expected
Last registry update
Results first posted
Primary completion
Started
Registered