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MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
Sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2019-09-29
Completion Date
2028-12-22
Last Updated
2026-07-10
Healthy Volunteers
No
Interventions
Mirdametinib (PD-0325901) oral capsule or dispersible tablet
Mirdametinib (PD-0325901) capsule or dispersible tablet
Locations (43)
University of Alabama at Birmingham/Children's of Alabama
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California - Irvine Health
Orange, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
University of California - Davis
Sacramento, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours A. I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
University of Florida Clinical Research Center
Gainesville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Moffitt
Tampa, Florida, United States
University of Illinois Hospital and Health Systems
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa Health Care
Iowa City, Iowa, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States
Albany Medical Center
Albany, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
UNC Medical Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
UC Health
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
The University of Utah Health Sciences Center
Salt Lake City, Utah, United States
University of Virginia - Emily Couric Cancer Center
Charlottesville, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States