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Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (Pediatric MATCH)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Ensartinib in Patients With Tumors Harboring ALK or ROS1 Genomic Alterations

  • Clinical Trial Information

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

  • IRB No: APEC1621F

    Protocol Abbrev: APEC1621F

    Principal Investigator: Amy A Smith, MD

    Phase: Drug: Phase II

    Age Group: Adult;Pediatric

    Secondary Protocol No: APEC1621F

    Treatment: Drug: Ensartinib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03213652

  • Objective

    To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with ensartinib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations.

  • Key Eligibility

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