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A Phase 1/2 Study of the Oral TRK Inhibitor Larotrectinib in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors

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Trial Profile

A Phase 1/2 Study of the Oral TRK Inhibitor Larotrectinib in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 Jun 2025

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At a glance

  • Drugs Larotrectinib (Primary)
  • Indications Carcinoma; CNS cancer; Glioma; Meningeal carcinomatosis; Neuroblastoma; Neuroepithelial neoplasms; Sarcoma; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SCOUT
  • Sponsors Bayer; Loxo Oncology

Most Recent Events

  • 10 Apr 2025 According to a Bayer media release,U.S. Food and Drug Administration (FDA) has granted full approval for VITRAKVI(larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion based on on data from LOXO-TRK-14001,SCOUT and NAVIGATE trial
  • 14 Sep 2024 This trial has been completed in Poland, according to European Clinical Trials Database record.
  • 14 Sep 2024 This trial has been completed in Poland, according to European Clinical Trials Database record.

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