(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:March 26, 2018
End Date:April 2023
Contact:Blueprint Medicines
Email:studydirector@blueprintmedicines.com
Phone:617-714-6707

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An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

This is an open-label, randomized, Phase 3 study in patients with locally advanced
unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus
regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.


Inclusion Criteria:

1. Patients who are ≥ 18 years of age.

2. Patients who have histologically confirmed metastatic or unresectable GIST.

3. Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens.
Patients who experienced intolerance to prior therapies must have objective disease
progression prior to enrollment onto BLU-285-1303 study.

4. Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS)
of 0 to 1.

Exclusion Criteria:

1. Patients who have received prior treatment with avapritinib or regorafenib.

2. Patients who have previously received more than 3 different TKI treatment regimens.

3. Patients who are known to be both V-kit Hardy-Zuckerman 4 feline sarcoma viral
oncogene homolog (KIT) and platelet-derived growth factor receptor alpha (PDGRFα) wild
type.

4. Patients who received any systemic anticancer therapy within 2 weeks before
randomization.

5. Patients with clinically significant cardiovascular disease, uncontrolled
thromboembolic disease, or significant risk of bleeding.

6. Patients who have a non-healing wound, ulcer, gastrointestinal perforation, or bone
fracture.

7. Patients who have poor organ function as defined by laboratory parameters specified in
the protocol.

8. Patients who have received neutrophil growth factor support within 14 days of
randomization.

9. Patients who require therapy with a concomitant medication that is a strong inhibitor
or strong inducer of CYP3A4.

10. Patients who have had a major surgical procedure within 14 days of randomization.
Patient has significant traumatic injury within 28 days before randomization.

11. Patients who have a history of another primary malignancy that has been diagnosed or
required therapy within 3 years before randomization.

12. Patients who have a history of a seizure disorder requiring anti-seizure medication.

13. Patients who have metastases to the brain.

14. Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450
msec.

15. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from
sexual intercourse or employ highly effective contraception from the time of
randomization and for at least 30 days after the last dose of study drug. Men who are
unwilling, if not surgically sterile, to abstain from sexual intercourse or employ
highly effective contraception from the time of randomization and for at least 90 days
after the last dose of study drug.

16. Women who are pregnant.

17. Women who are breastfeeding.

18. Patients who have prior or ongoing clinically significant illness, medical condition,
surgical history, physical finding, or laboratory abnormality as determined by the
investigator.
We found this trial at
28
sites
Philadelphia, Pennsylvania 19111
Principal Investigator: Margaret von Mehren
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Philadelphia, PA
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Jonathan C. Trent
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Lee Cranmer
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Seattle, WA
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Adelaide, 5042
Principal Investigator: Amitesh C. Roy
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Adelaide,
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Scott M. Schuetze
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Rodolfo Bordoni
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, GA
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Victor Villalobos
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Suzanne George
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, Illinois 60611
Principal Investigator: Mark Agulnik
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Chicago, IL
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: David A. Liebner
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Dallas, Texas 75246
Principal Investigator: Andrew D. McCollum
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Dallas, TX
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Jennifer Choe
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Houston, Texas 77030
Principal Investigator: Shreyaskumar Patel
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Houston, TX
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Jacksonville, Florida 32224
Principal Investigator: Steven Attia
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Jacksonville, FL
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Milwaukee, Wisconsin 53226
Principal Investigator: John Charlson
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Milwaukee, WI
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna C. Bendell
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: William Tap
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Phoenix, Arizona 85054
Principal Investigator: Mahesh Seetharam
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Melissa Burgess
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Pittsburgh, PA
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3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
503 494-7999
Principal Investigator: Michael Heinrich
OHSU Knight Cancer Institute OHSU Knight Cancer Institute is known worldwide for our contributions to...
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Portland, OR
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Scott H. Okuno
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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Saint Louis, Missouri 63110
Principal Investigator: Brian Van Tine
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Saint Louis, MO
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Salt Lake City, Utah 84112
Principal Investigator: Jonathan Whisenant
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Salt Lake City, UT
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Santa Monica, California 90404
Principal Investigator: Arun S. Singh
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Santa Monica, CA
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6001 North Mayfair Street
Spokane, Washington 99208
Principal Investigator: Arvind Chaudhry
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Spokane, WA
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Tampa, Florida 33612
Principal Investigator: Mihaela Druta
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Tampa, FL
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Waco, Texas 76712
Principal Investigator: Thomas J. Harris
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Waco, TX
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Washington, District of Columbia 20010
Principal Investigator: Dennis A. Priebat
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Washington,
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