Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Previous Page Next Page

Clinical Data

Larotrectinib efficacy and safety have been evaluated in three clinical trials in patients with cancers with NTRK gene fusion [1-3]. Patients were to have unresectable or metastatic solid tumours progressing following systemic therapy or requiring surgery with substantial morbidity for locally-advanced disease [1, 2].

Patients were prospectively identified as carrying the NTRK gene fusion, detected by molecular profiling as routinely performed at each site, and consecutively enrolled into one of three open-label, single-arm protocols [1, 2]:

  • A phase 1 study in adults (LOXO-TRK-14001; NCT02122913);
  • A phase 1/2 study in children (SCOUT; NCT02637687); and
  • A phase 2 “basket” study in adolescents and adults (NAVIGATE; NCT02576431).

Patients with and without documented NTRK gene fusion were allowed to participate in LOXO-TRK-14001 and SCOUT. Patients enrolled to NAVIGATE were required to have TRK fusion-positive cancer.

Click on the following links to learn more about the currently available efficacy and safety outcomes from these trials.


  1. VITRAKVI® (larotrectinib), USA Prescribing Information. 2021.
  2. VITRAKVI® (larotrectinib), EMA Summary of medicinal Product Characteristics. 2022.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.