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Protocol No. APEC1621A

Principal Investigator DeSantes, Kenneth

Phase I/II Pilot

Age Group Children

Scope National

Sponsor Type National

Title NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)-Phase 2 subprotocol of LOXO-101 in patients with tumors harboring actionable NTRK fusions

This is a Phase 2 study of a drug called LOXO-101 (larotrectinib). In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on tumors.
LOXO-101 (larotrectinib) works by blocking proteins cell signal proteins that are thought to be important for tumors to grow. We are using LOXO-101 (larotrectinib) in this study because it has been shown to block the growth of cancer cells with mutations in NTRK pathway in test tubes and in animals. LOXO-101 (larotrectinib) is considered a study drug in the treatment of tumors. Although LOXO-101 (larotrectinib) has been given to a small number of children, we do not know if it will work against this type of tumors.
The Phase 1 study of LOXO-101 (larotrectinib) in children with cancer is ongoing. The goal of Phase 1 studies is to find the highest dose of a study drug that can be given without too many side effects. In the ongoing Phase 1 study, researchers have determined the dose of LOXO-101 (larotrectinib) to be used in this study; that can be given without too many side effects in children.

Treatment LOXO-101 (larotrectinib) will be given by mouth twice a day for 28 days, for up to 2 years unless disease progression or intolerable adverse events

Description Phase 2 Pediatric MATCH sub protocol of LOXO-101 for NTRK fusions

Key Eligibility
  • Patients must be ≥ than 12 months and ≤ 21 years of age
  • Patients must have radiographically measurable disease
  • Patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible
  • Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
  • ≥ 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
  • ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1
  • If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid
  • ≥ 14 days after the last dose of a longacting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor
  • ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
  • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including DLI or boost infusion: ≥ 84 days after infusion and no evidence of GVHD
  • Autologous stem cell infusion including boost infusion: ≥ 42 days
  • ≥ 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
  • ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial BM radiation
  • ≥ 42 days after systemically administered radiopharmaceutical therapy
  • Must have adequate bone marrow, renal, liver and neurological function
  • Can not be pregnant or breastfeeding
  • Male and Female must use adequate birth control
  • Patients who have received prior therapy with a specific inhibitor of TRK (including but not limited to entrectinib (RXDX-101), DS-6051b, and PLX7486) are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible

  • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics