Finding your way with GIST?

Consider NAVIGATOR - a clinical trial of avapritinib for people with advanced GIST. This trial is currently enrolling patients who have progressed following first-line treatment with imatinib (Gleevec®).

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About the NAVIGATOR clinical trial

The NAVIGATOR clinical trial will test an investigational drug called avapritinib in people with advanced GIST. The trial is currently enrolling patients who have progressed following treatment with imatinib (Gleevec®). It is a phase 1 trial designed to test the safety and initial clinical activity of avapritinib.

Information about GIST

All cancers begin when one or more genes in a cell are mutated (altered) and the cell starts to divide and grow out of control. Identifying these genes is important because drugs can be developed to target them.

For example, we know that specific mutations (alterations) in the genes for KIT and PDGFRA are involved in the development of GIST. These genes provide the instructions for producing types of proteins called tyrosine kinase receptors that are involved in signaling cell growth and division. Avapritinib is an investigational drug that was specifically designed to inhibit (block) mutated forms of KIT and PDGFRA.

Who is eligible
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Who is eligible to participate in the NAVIGATOR clinical trial?

You may be able to take part in NAVIGATOR clinical trial if you:

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

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

    Group 3: Have progressed following first-line treatment with imatinib

  • Are not eligible for surgery for your GIST

  • Are at least 18 years old

    • Other eligibility criteria apply and these will be assessed at screening.
    • *Presence of a D842V mutation in PDGFRα may be identified by your doctor with a tumor biopsy. If it is found that you have this mutation, you will be eligible to enroll in the trial whether you have been previously treated for it or not.

About the investigational drug
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About the investigational drug

If you take part in the NAVIGATOR clinical trial, you will receive the investigational drug avapritinib. Avapritinib comes in a tablet form, and should be swallowed whole with water, once a day.

What does taking part involve?
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What does taking part in the NAVIGATOR clinical trial involve?

*There is no maximum duration for this trial. You will continue with your cycles of treatment until:

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

About NAVIGATOR clinic visits
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NAVIGATOR trial clinic visits

During the trial, a variety of health assessments will be conducted to see how you are responding to the investigational drug. In most cases, these assessments will be done at a clinical site.

Health assessments will vary between visits, but may include:

MRI or CT scan

Vital signs(temperature, blood pressure, heart rate and weight)

ECG(painless heart scan)

Blood tests

More information about health assessments and visit length will be found in the informed consent form, which you will need to read and sign if you want to take part in the NAVIGATOR clinical trial.

How often will these visits take place?*

Cycle 1

3 times

Cycle 2

Once per cycle

Cycle 3 onwards

Once per cycle

*Please note these numbers are approximations and apply only to Group 3 patients who have progressed on imatinib. One treatment cycle is 28 days.

Find a trial site
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Where is the NAVIGATOR clinical trial taking place?

Belgium

Leuven Cancer Institute University Hospitals Leuven, Leuven

France

Centre Leon Berard, Lyon

Institut Gustave Roussy, Paris

Germany

University of Duisburg-Essen, Essen

Italy

Fondazione IRCCS - Istituto Nazinale dei Tumori, Milano

Netherlands

Erasmus MC Cancer Institute, Rotterdam

Poland

Centrum Onkologii-Instytut im. Marii Skłodowskiej-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 Center, 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 Cancer Center, Houston, TX

More information about this clinical trial, including participating trial sites, is available on ClinicalTrials.gov. Last updated: September 26, 2018.

How can I learn more about the NAVIGATOR trial?

If you think you meet the criteria specified above and are interested in taking part in the NAVIGATOR trial, or you would simply like more information, please call: +1 617-714-6707 or email: NAVIGATOR@blueprintmedicines.com. A member of our team will talk you through the next steps and will connect you to a suitable trial doctor.

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