A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors (NAVIGATE)

  • STATUS
    Recruiting
  • End date
    Aug 29, 2025
  • participants needed
    204
  • sponsor
    Bayer
Updated on 21 July 2022
cancer
tyrosine
measurable disease
breast cancer
lung cancer
NTRK
lung carcinoma

Summary

This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

Description

The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults.

Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.

Details
Condition Solid Tumors Harboring NTRK Fusion
Treatment LOXO-101, Larotrectinib LOXO-101, BAY2757556 (Larotrectinib, Vitrakvi)
Clinical Study IdentifierNCT02576431
SponsorBayer
Last Modified on21 July 2022

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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