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KiTZ Clinical Trial Unit

Head: Prof. Dr. med. Olaf Witt
Deputy head: Prof. Dr. med. Stefan Pfister

Im Neuenheimer Feld 430
D-69120 Heidelberg

TRK-inhibitor Larotrectinib in children with advanced solid or primary tumors of the central nervous system

"Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Sold or Primary Central Nervous System Tumors."

In this study, children and adolescents aged 1 to 21 years with an advanced or metastatic solid tumor - a primary central nervous system tumor or IFS (infantile fibrosarcoma) - are being treated with the drug LOXO-101 (larotrectinib). Larotrectinib specifically inhibits tropomyosin receptor kinases (TRK), a group of signaling proteins that play an important role in cellular communication and tumor growth. The study will therefore treat tumors with altered genetic information in this area (NTRK fusion) and in which the tumor has recurred or progressed after standard therapy. Larotrectinib is taken orally continuously over a 28-day cycle.

Recruitment ended in April 2023.

Key inclusion criteria for phase 2:

  • Children and adolescents between 0 and 21 years of age with a locally advanced or metastatic IF with a positive ETS gene variation 6 (ETV6) detected by FISH or by molecular analysis.
  • Children and adolescents between 0 and 21 years of age with a locally advanced solid tumor or a primary CNS tumor with proven NTRK gene fusion
  • At least one measurable lesion according to RECIST or RANO
  • Karnofsky or Lansky > 50

For more information, see the study registry: The study is registered with the "U.S. National Institutes of Health" (ClinicalTrials.gov).
See NCT02637687

EudraCT-Number: 2016-003498-16