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NAVIGATE

A trial looking at a drug called larotrectinib for people with locally advanced or advanced cancer with a defect in a specific gene (NAVIGATE).

Research title: A phase 2 study of the oral TRK-inhibitor LOXO-101 (larotrectinib) in participants with NTRK gene fusion solid tumours.

Why is this trial being carried out?

The cells that make up our body are controlled by genes. Genes give instructions to our cells to tell them when to grow and divide to keep our body working properly. Sometimes these genes can be faulty.

This phase 2 clinical trial, called NAVIGATE, is looking at a gene called NTRK. This gene helps to control how our cells grow and behave. A fault in this gene is called an NTRK-fusion gene defect. This defect can lead to the development of different types of cancer – including pancreatic cancer.

Researchers have been looking at whether a drug called larotrectinib can slow down the development of cancer in people that have the NTRK-fusion gene defect. This research has shown good results in a small number of people with different types of cancer. The NAVIGATE trial will continue this research with a larger group of people with different types of cancer.

The trial will find out if the drug larotrectinib can reduce the size of the cancer, and stop it from growing any more. Researchers want to learn more about the drug, and if it has any side effects.

Who is the trial suitable for?

NAVIGATE is for people with locally advanced or advanced cancer. Locally advanced cancer is cancer that has started growing into the organs or large blood vessels surrounding the tumour. Advanced cancer is cancer that has spread to other parts of the body, and can’t be removed with surgery.

The NAVIGATE trial may be suitable for you if:

  • you have locally advanced or advanced cancer
  • you have a fusion of the gene NTRK-1/-2/-3 — you will have tests to check this, and your doctor or nurse can discuss this with you
  • you have had treatment for your cancer, such as surgery, chemotherapy or radiotherapy
  • your organs, such as your liver and kidneys, are working properly — you will have tests to check this.

There may be reasons for not being able to take part in this clinical trial. It is important to speak to your doctor or nurse about whether the NAVIGATE trial might be suitable for you.

What does this trial involve?

Before taking part, you will have tests to find out if you have the NTRK-fusion gene defect.

These tests may include blood tests and having a tissue sample (a biopsy) taken from your tumour. If you have had a biopsy or surgery at an earlier stage, researchers may be able to test the sample that was taken then – your doctor or nurse can talk to you about this.

If you take part in this trial you will take a larotrectinib tablet twice a day, for as long as the treatment is helping you, and you don’t have any bad side effects. During the trial you will have a scan every 2 months to see how your tumour is responding to larotrectinib treatment.

Recruitment start date: Oct 2015

Recruitment end date: June 2020

  • Trial centres

    The NAVIGATE trial will be carried out in:

    • Bart’s Health NHS Trust, Royal London Hospital
    • University College Hospital, London
    • University Hospital Southampton

    Trial lead

    David Propper

    Contact information

    You can contact the trial centre by email on: clinicaltrials@loxooncology.com

  • How to join a trial

    Please speak to your consultant about whether this trial is suitable for you.

    If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.

    How to find out more

    For further information about this trial go to the clinicaltrials.gov website.

Information Standard

Published: February 2019

Review Date: February 2021