Last updated on August 2019

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

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

EXPLORATORY OBJECTIVES:

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

OUTLINE

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

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Louisville, KY United States
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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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