About the NAVIGATOR clinical trial

NAVIGATOR is a phase 1 clinical trial that is designed to test the safety and clinical activity of an investigational drug called avapritinib in people with advanced gastrointestinal tumors (GIST).

Avapritinib selectively targets two kinase proteins called KIT and PDGFRα. Certain mutations (genetic alterations) in these proteins are known to be involved in the development of GIST. In fact, 80% of people with GIST have one or more KIT mutations, and around 5-6% have a specific mutation in PDGFRα called D842V. Avapritinib was developed to selectively target these mutated proteins, and inhibit (block) their activity. Avapritinib is an investigational drug currently being evaluated in clinical trials. It is an oral drug that is taken by mouth once a day.

What is the NAVIGATOR clinical trial?

Trial phase: Phase 1

Trial status: Active and recruiting participants

Enrollment goal: 250 people

Chance of receiving active treatment

Who is eligible to participate in the NAVIGATOR clinical trial?

  • Have gastrointestinal stromal tumors (GIST)* that:

    Group 1:Has progressed following treatment with imatinib and at least 1 additional tyrosine kinase inhibitor (third-line or later treatment).
    Please note that Group 1 is fully enrolled and is no longer accepting new patients.

    Group 2:Has a confirmed D842V mutation in the PDGFRα gene*.
    Please note that Group 2 is fully enrolled and is no longer accepting new patients.

    Group 3:Has progressed following treatment with imatinib (second-line treatment)

  • Unresectable disease (ineligible for surgery)

    • If you do have a PDGFRα D842V mutation, you may be able to enroll in this trial if you have not previously been treated or you have received one or more medicines for your disease.

What does participation in the NAVIGATOR clinical trial involve?

  • Informed consent

    Before you can enroll in NAVIGATOR, you will need to review and sign an informed consent form with your doctor. The purpose of the informed consent form is to ensure you understand the risks and benefits of taking part.

  • Screening visit

    To assess your eligibility to take part. Screening assessments will take place at a trial site.

  • Dosing period

    All participants will receive the investigational drug. We will also need to carry out some health assessments to see how you are responding to the investigational drug.

  • During the trial, participants receive the investigational drug once daily until:

    • Your disease worsens
    • You can’t tolerate any side effects you may have
    • The trial doctor decides you should leave the trial
    • You decide to leave the trial
    • The company running the trial decides to end it

What health assessments will take place during the NAVIGATOR clinical trial?

Health assessments will vary from visit to visit, but may include:

Physical exam

Blood tests

Tumor imaging by computerized tomography (CT) and/or magnetic resonance imagine (MRI)

Heart monitoring (ECG)

Safety monitoring

Additional assessments may be required and will be explained to you by the trial doctor.

Where is the NAVIGATOR clinical trial taking place?

  • Belgium

    • Leuven Cancer Institute University Hospitals
      Leuven

  • France

    • Centre Leon Berard
      Lyon
    • Institut Gustave Roussy
      Paris
  • Germany

    • University Duisburg-Essen
      Essen
  • Italy

    • Fondazione IRCCS - Istituto Nazinale dei Tumori
      Milan
  • Netherlands

    • Erasmus MC Cancer Institute
      Rotterdam
  • Poland

    • Centrum Onkologii-Instytut im, Marii Sklodowskiej-Curie w Warszawie
      Warsaw
  • Republic of Korea

    • Asan Medical Center
      Seoul
  • Spain

    • Vall d’Hebron Institute of Oncology (VHIO)
      Barcelona
  • United Kingdom

    • Royal Marsden Hospital
      London
  • United States

    • Sarcoma Oncology
      Santa Monica, CA
    • Sylvester Comprehensive Cancer Center
      Miami, FL
    • Dana Farber Cancer Institute
      Boston, MA
    • Memorial Sloan Kettering Cancer Center
      New York, NY
    • Oregon Health and Science University
      Portland, OR
    • Fox Chase Cancer Center
      Philadelphia, PA
    • MD Anderson
      Houston TX

A travel support program is available for participants and caregivers to reduce out-of-pocket expenses and ensure travel to the trial site is simple and comfortable.

More information about this clinical trial, including participating trial sites, is available on ClinicalTrials.gov

Where do I get more information about the NAVIGATOR clinical trial?

If you think you meet the criteria specified above and are interested in taking part in the NAVIGATOR clinical trial, or you would simply like more information, please call: 617-714-6707 or email studydirector@blueprintmedicines.com A member of our team will talk you through the next steps, and will connect you to a suitable trial doctor.