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PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (Pediatric MATCH)

NCI-COG Pediatric MATCH (Molecular Analysis For Therapy Choice)- Phase 2 Subprotocol of LY3023414 in Patients With Solid Tumors

  • Clinical Trial Information

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

  • IRB No: APEC1621D

    Protocol Abbrev: APEC1621D

    Principal Investigator: Amy A Smith, MD

    Phase: Drug: Phase II

    Age Group: Adult;Pediatric

    Secondary Protocol No: APEC1621D

    Treatment: Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: Samotolisib

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03213678

  • Objective

    To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with PI3K/mTOR inhibitor LY3023414 (LY3023414) with advanced solid tumors, non-Hodgkin lymphomas or central nervous system (CNS) tumors that harbor TSC loss of function mutations, that harbor other PI3K/MTOR activating mutations, and if efficacy is observed in a MATCHed cohort, in patients that lack mutations in the PI3K/MTOR pathway.

  • Key Eligibility

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