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

Completed · Phase 3

Conditions studied: GIST

In brief

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.

Key facts

Study ID: NCT03465722
Run by: Blueprint Medicines Corporation
People needed: 476
Starts: 2018-03-26
Expected to finish: 2021-09-15
Last updated by the study team: 2022-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients who are ≥ 18 years of age.
Patients who have histologically confirmed metastatic or unresectable GIST.
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.
Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.

You may not qualify if…

Patients who have received prior treatment with avapritinib or regorafenib.
Patients who have previously received more than 3 different TKI treatment regimens.
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.
Patients who received any systemic anticancer therapy within 1 week before the first dose of study drug.
Patients who have clinically significant cardiovascular disease
Patients have experienced arterial thrombotic or embolic events within 6 months before the first dose of study drug, or venous thrombotic events within 14 days of the first dose of study drug
Patients who have experienced any hemorrhage or bleeding event NCI CTCAE version 5.0 Grade 3 or higher within 4 weeks before the first dose of study drug
Patients who have a known risk of intracranial bleeding, or a history of intracranial bleeding within 1 year prior to the first dose of study drug
Patients who have a symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture.
Patients who have poor organ function as defined by laboratory parameters specified in the protocol.
Patients who have received neutrophil growth factor support within 14 days of first dose of study drug.
Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4.
Patients who have had a major surgical procedure within 14 days of the first dose of study drug. Patient has significant traumatic injury within 28 days before the first dose of study drug.
Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 3 years before first dose of study drug.
Patients who have a history of a seizure disorder requiring anti-seizure medication.
Patients who have metastases to the brain.
Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec.
Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of the first dose of study drug and for at least 60 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 the first dose of study drug and for at least 90 days after the last dose of study drug.
Women who are pregnant.
Women who are breastfeeding.
Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality as determined by the investigator.

Where it is running

UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
University of Colorado Hospital — Aurora, Colorado, United States
Rocky Mountain Cancer Centers — Boulder, Colorado, United States
Washington Hospital Center - Oncology and Hematology — Washington D.C., District of Columbia, United States
Mayo Clinic Cancer Center — Jacksonville, Florida, United States
University of Miami — Miami, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Northside Hospital — Atlanta, Georgia, United States
Northwestern Medicine — Chicago, Illinois, United States
The University of Chicago Medical Center — Chicago, Illinois, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center — Rochester, Minnesota, United States
Washington University in Saint Louis — St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
Ohio State University — Columbus, Ohio, United States
OHSU - Knight Cancer Institute — Portland, Oregon, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
Tennessee Oncology — Nashville, Tennessee, United States
USO - Texas Oncology — Dallas, Texas, United States
Texas Oncology - Denton South — Denton, Texas, United States
University of Texas MD Anderson — Houston, Texas, United States
Mayo Clinic Cancer Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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