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A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion

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Trial Profile

A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion

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

Latest Information Update: 30 Jun 2025

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At a glance

  • Drugs Larotrectinib (Primary)
  • Indications Advanced breast cancer; Appendiceal cancer; Biliary cancer; Carcinoma; Cholangiocarcinoma; CNS cancer; Colorectal cancer; Duodenal cancer; Gastric cancer; Glioma; Head and neck cancer; Liver cancer; Lung cancer; Male breast cancer; Malignant melanoma; Meningeal carcinomatosis; Neuroblastoma; Neuroepithelial neoplasms; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Renal cancer; Salivary gland cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Thyroid cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NAVIGATE
  • Sponsors Bayer; Loxo Oncology

Most Recent Events

  • 13 May 2025 Planned End Date changed from 30 Nov 2025 to 31 Oct 2025.
  • 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
  • 12 Mar 2025 Planned End Date changed from 31 Oct 2025 to 30 Nov 2025.

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