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Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (Pediatric MATCH)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Tazemetostat in Patients With Tumors Harboring Alterations in EZH2 or Members of the SWI/SNF Complex

  • Clinical Trial Information

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

  • IRB No: APEC1621C

    Protocol Abbrev: APEC1621C

    Principal Investigator: Amy A Smith, MD

    Phase: Drug: Phase II

    Age Group: Adult;Pediatric

    Secondary Protocol No: APEC1621C

    Treatment: Drug: Tazemetostat

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03213665

  • Objective

    To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with tazemetostat with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphoma or histiocytic disorders that harbor gain of function mutations in EZH2, or loss of function mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4 at a dose of 520 mg/m^2/dose twice daily for patients without any CNS involvement or 1200 mg/m^2/dose orally twice daily for patients with CNS involvement

  • Key Eligibility

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