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Spots Global Cancer Trial Database for MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

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Trial Identification

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

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

Study ID: NCT03962543

Study Description

Brief 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.

Detailed Description: Neurofibromas are benign peripheral nerve sheath tumors, which are classified as plexiform neurofibromas (PNs) if they extend longitudinally along a nerve and involve multiple fascicles. PNs are a major cause of morbidity and disfigurement in individuals with NF1, and as the tumor growth progresses, can cause a multitude of clinical deficits including pain and impaired physical function. PNs have the potential to undergo malignant transformation to Malignant Peripheral Nerve Sheet Tumors (MPNST). Mirdametinib (PD-0325901) is an orally delivered, highly selective small-molecule inhibitor of the dual specificity kinases, MEK1 and MEK2 (MAPK/ERK Kinase) which prevents the phosphorylation and subsequent activation of mitogen-activated protein kinase (MAPK). Previous studies of mirdametinib (PD-0325901) demonstrated PN shrinkage and sustained inhibition of pERK. Reduced tumor volume indicated that cell proliferation or cell death may be altered in PNs with administration of mirdametinib (PD-0325901).

Eligibility

Minimum Age: 2 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, 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, Saint 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, Saint 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, 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

Contact Details

Name: Christopher L Moertel, MD

Affiliation: University of Minnesota

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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