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A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

  • Clinical Trial Information

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

  • IRB No: 19.265.10

    Protocol Abbrev: TPX-0005-07

    Principal Investigator: Kalpana Vikram Patel, MD

    Phase: Drug: Phase I

    Age Group: Pediatric

    Secondary Protocol No: TPX-0005-07

    Treatment: Drug: Oral repotrectinib (TPX-0005)

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT04094610

  • Objective

    Phase 1
    •   Evaluate the safety and tolerability at
    different dose levels of repotrectinib in
    pediatric and young adult subjects with
    advanced or metastatic malignancies
    harboring ALK, ROS1, or NTRK1-3
    alterations to estimate the MTD or MAD
    and select the pediatric RP2D/schedule.

    Phase 2
    •   Determine the anti-tumor activity of
    repotrectinib in pediatric and young adult
    subjects with advanced or metastatic
    malignancies harboring ALK, ROS1, or
    NTRK1-3 alterations.

  • Key Eligibility

    Key Inclusion Criteria:
    1.Documented genetic ALK, ROS1, or NTRK1-3 alteration (point mutation, fusion, amplification) as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.
    2.Age 4 to <12 years.
    3.Capability to swallow capsules intact (without chewing, crushing, or opening).
    4.Prior cytotoxic chemotherapy is allowed.
    5.Prior immunotherapy is allowed.
    6.Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
    7.All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology Criteria (RANO) criteria at time of enrollment.
    8.Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 14 days prior to enrollment.
    9.Subjects must have a Lansky (< 16 years) score of at least 50.
    10.Life expectancy greater than or equal to 12 weeks.
    11.Adequate hematologic, renal and hepatic function.