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MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
Sponsor: SpringWorks Therapeutics, Inc.
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
2026-04-08
Healthy Volunteers
No
Interventions
Mirdametinib (PD-0325901) oral capsule or dispersible tablet
Mirdametinib (PD-0325901) capsule or dispersible tablet
Locations (50)
University of Alabama at Birmingham/Children's of Alabama
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
UCLA Oncology Center
Los Angeles, California, United States
University of California - Irvine Health
Orange, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
University of California - Davis Comprehensive Cancer Center
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 Medical Center
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
AdventHealth Pediatric Oncology Hematology at Orlando
Orlando, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
University of Illinois Hospital and Health Systems
Chicago, Illinois, United States
University of Chicago Medical Centers
Chicago, Illinois, United States
IU Health Brain Tumor Infusion Clinic
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
University of Michigan CS Mott Children's Hospital
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 School of Medicine-Siteman Cancer Center
St Louis, Missouri, United States
St. Joseph's Univeristy 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
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Children's Medical Center
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah, Center for Clinical and Translational Sciences
Salt Lake City, Utah, United States
UVA Health, Division of Neuro-Oncology
Charlottesville, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington, United States
MACC Fund Research Center
Milwaukee, Wisconsin, United States