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Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of BVD-523FB (Ulixertinib) in Patients With Tumors Harboring Activating MAPK Pathway Mutations

  • Clinical Trial Information

    Trial Contact: Cevallos, Claudia; El-Shami, Jessica; Leffin, Melissa; Spinelli, Jennifer

  • IRB No: APEC1621J

    Protocol Abbrev: APEC1621J

    Principal Investigator: Amy A Smith, MD

    Phase: Drug: Phase II

    Age Group: Adult;Pediatric

    Secondary Protocol No: APEC1621J

    Treatment: Other: Pharmacokinetic Study; Drug: Ulixertinib

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03698994

  • Objective

    To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with BVD-523FB (ulixertinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in the MAPK pathway.

  • Key Eligibility

    Sexes Eligible for Study - All
    Ages - 12 Months to 21 Years (Child, Adult)
    Accepts Healthy Volunteers - No