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Larotrectinib in Treating Patients With Relapsed/Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-101 (Larotrectinib) in Patients With Tumors Harboring Actionable NTRK Fusions

  • Clinical Trial Information

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

  • IRB No: APEC1621A

    Protocol Abbrev: APEC1621A

    Principal Investigator: Amy A Smith, MD

    Phase: Drug: Phase II

    Age Group: Adult;Pediatric

    Secondary Protocol No: APEC1621A

    Treatment: Drug: Larotrectinib; Drug: Larotrectinib Sulfate

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03213704

  • Objective

    To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with LOXO-101 (larotrectinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders harboring NTRK 1/2/3 fusions.

  • Key Eligibility

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