Last updated on August 2020

Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors Non-Hodgkin Lymphoma or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

Brief description of study

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Study Description


I. 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.


I. To estimate the progression free survival in pediatric patients treated with LOXO-101 (larotrectinib) with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders with NTRK 1/2/3 fusions.

II. To obtain additional information about the tolerability of LOXO-101 (larotrectinib) in children with relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics of LOXO-101 (larotrectinib) in children with relapsed or refractory cancer.


I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).


Patients receive larotrectinib sulfate orally (PO) or via nasogastric (NG)- or gastric (G)-tube twice per day (BID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then periodically thereafter.

Clinical Study Identifier: NCT03213704

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Ochsner Medical Center Jefferson

New Orleans, LA United States
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Sinai Hospital of Baltimore

Baltimore, MD United States
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Kaiser Permanente-Oakland

Oakland, CA United States
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Children's Hospital of Alabama

Birmingham, AL United States
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Arkansas Children's Hospital

Little Rock, AR United States
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Children's Hospital Los Angeles

Los Angeles, CA United States
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Nemours Children's Hospital

Orlando, FL United States
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Saint Mary's Hospital

West Palm Beach, FL United States
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Blank Children's Hospital

Des Moines, IA United States
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Norton Children's Hospital

Louisville, KY United States
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Children's Hospital New Orleans

New Orleans, LA United States
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C S Mott Children's Hospital

Ann Arbor, MI United States
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Saint Peter's University Hospital

New Brunswick, NJ United States
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Geisinger Medical Center

Danville, PA United States
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Cook Children's Medical Center

Fort Worth, TX United States
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Seattle Children's Hospital

Seattle, WA United States
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Yale University

New Haven, CT United States
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M D Anderson Cancer Center

Houston, TX United States
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AdventHealth Orlando

Orlando, FL United States
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Driscoll Children's Hospital

Corpus Christi, TX United States
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Mission Hospital

Asheville, NC United States
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Bronson Methodist Hospital

Kalamazoo, MI United States
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Recruitment Status: Open

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