Finding your way with GIST?

A clinical trial of avapritinib versus regorafenib (Stivarga®) for people with advanced GIST that has progressed following first-line treatment with imatinib (Gleevec®) and one or two additional treatment regimens (third-line or fourth-line GIST).

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About the VOYAGER clinical trial

The VOYAGER clinical trial will test an investigational drug called avapritinib, in people with advanced gastrointestinal stromal tumors (GIST), that has progressed following two or three prior treatment regimens. The main aim of the trial is to see how effective avapritinib is compared to an existing GIST treatment called regorafenib (Stivarga®).

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 VOYAGER clinical trial?

You may be eligible to take part in the VOYAGER clinical trial if you:

Have a gastrointestinal stromal tumor (GIST) that has progressed following first-line treatment with imatinib (Gleevec®) and one or two additional treatment regimens (third-line or fourth-line GIST)

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.

About the study drugs
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About the study drugs

If you take part in the VOYAGER clinical trial, you would randomly receive either:

  • The investigational drug, avapritinib – a 50% chance
  • An approved GIST therapy, regorafenib (Stivarga®) – a 50% chance

If you are assigned to the regorafenib (Stivarga®) group and your disease progresses, you will still have the opportunity to receive avapritinib.

Both study drugs come in tablet form and should be swallowed whole with water, as directed.

What does taking part involve?
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What does taking part in the VOYAGER 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 VOYAGER clinic visits
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VOYAGER 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 and urine tests

Questionnaires

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 VOYAGER clinical trial.

How often will these visits take place?*

Cycles 1-3

Once per cycle

Cycle 4 onwards (e.g., cycle 5, 7, etc.)

Every odd cycle

*Please note that these numbers are approximate. One treatment cycle is 28 days.

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

Australia

Monash Health, Clayton

Canada

University Health Network, Toronto

France

Institute Bergonié, Bordeaux

Gustave Roussy Cancer Campus, Villejuif

UNICANCER - Lyon, Centre Léon-Bérard, Lyon

Republic of Korea

Severance Hospital, Seoul

Asan Medical Center, Seoul

Seoul National University Hospital, Seoul

Sweden

Lunds University Hospital, Lund

United Kingdom

Royal Marsden Hospital, London

United States

Mayo Clinic Cancer Center, Phoenix, AZ

University of Miami Hospitals and Clinics, Sylvester Comprehensive Cancer Center, Miami, FL

Moffitt Cancer Center, Tampa, FL

Mayo Clinic Cancer Center, Jacksonville, FL

Dana Farber Cancer Institute, Boston, MA

University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

Mayo Clinic Cancer Center, Rochester, MN

Washington University in Saint Louis, Saint Louis, MO

Memorial Sloan Kettering Cancer Center, New York, NY

Ohio State University, Columbus, OH

UPMC Hillman Cancer Center, Pittsburgh, PA

Fox Chase Cancer Center, Philadelphia, PA

Tennessee Oncology, Nashville, TN

MD Anderson Cancer Center, Houston, TX

Summit Cancer Centers, Spokane, WA

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 VOYAGER trial?

If you think you meet the criteria specified above and are interested in taking part in the VOYAGER trial, or you would simply like more information, please call: +1 617-714-6707 or email: SM@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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