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A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors

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Trial Profile

A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Apr 2025

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At a glance

  • Drugs Larotrectinib (Primary)
  • Indications Adenocarcinoma; Carcinoma; Lung cancer; Non-small cell lung cancer; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; First in man
  • 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
  • 04 Jun 2024 Results (n=31; As of July 20, 2023) assessing the long-term efficacy and safety in a subset of patients with TRK fusion thyroid carcinoma treated with larotrectinib from NCT02576431, NCT02122913, NCT02637687 trials, presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 16 May 2024 According to a Bayer media release, data from this study will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, United States, from May 31-June 4, 2024.

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