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
Latest Information Update: 20 May 2025
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.