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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Study ID
NCT03962543
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Neurofibromatosis Type 1 (NF1)
  • Plexiform Neurofibroma

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
May 24, 2019
Start date
Sep 29, 2019
Status verified
Jun 2026
Primary completion
Sep 20, 2023
Completion
Dec 22, 2028

Study Design

Enrollment
114 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mirdametinib (PD-0325901)
    Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily

Primary Outcome Measure

Confirmed Objective Response Rate at the End of the Treatment Phase. [ Time Frame: Up to 24 months ]

Locations (43)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham/Children's of AlabamaBirminghamAlabama35233-
Mayo Clinic ArizonaPhoenixArizona98195-
Arkansas Children's HospitalLittle RockArkansas72202-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
University of California, Los Angeles (UCLA)Los AngelesCalifornia90095-
Children's Hospital of Orange CountyOrangeCalifornia92868-
University of California - Irvine HealthOrangeCalifornia92868-
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304-
University of California - DavisSacramentoCalifornia95817-
Children's Hospital ColoradoAuroraColorado80045-
Nemours A. I. duPont Hospital for ChildrenWilmingtonDelaware19803-
Children's National HospitalWashington D.C.District of Columbia20010-
University of Florida Clinical Research CenterGainesvilleFlorida32610-
Nicklaus Children's HospitalMiamiFlorida33155-
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
MoffittTampaFlorida33612-
University of Illinois Hospital and Health SystemsChicagoIllinois60612-
Indiana UniversityIndianapolisIndiana46202-
University of Iowa Health CareIowa CityIowa52242-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55905-
Washington UniversitySt LouisMissouri63110-
Saint Joseph's Regional Medical CenterPatersonNew Jersey07503-
Albany Medical CenterAlbanyNew York12208-
Children's Hospital at MontefioreThe BronxNew York10467-
UNC Medical CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
UC HealthCincinnatiOhio45219-
Nationwide Children's HospitalColumbusOhio43205-
University of Oklahoma - Health Sciences CenterOklahoma CityOklahoma73104-
Oregon Health and Science UniversityPortlandOregon97239-
Children's Hospital of Pittsburgh UPMCPittsburghPennsylvania15219-2739-
Vanderbilt Children's HospitalNashvilleTennessee37232-
University of Texas SouthwesternDallasTexas75244-
Cook Children's Medical CenterFort WorthTexas76104-
MD Anderson Cancer CenterHoustonTexas77030-
The University of Utah Health Sciences CenterSalt Lake CityUtah84108-
University of Virginia - Emily Couric Cancer CenterCharlottesvilleVirginia22903-
Children's Hospital of The King's DaughtersNorfolkVirginia23510-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham/Children's of Alabama· Birmingham, ALMayo Clinic Arizona· Phoenix, AZArkansas Children's Hospital· Little Rock, ARChildren's Hospital Los Angeles· Los Angeles, CAUniversity of California, Los Angeles (UCLA)· Los Angeles, CAChildren's Hospital of Orange County· Orange, CA

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