(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or M… (NCT03465722) | Clinical Trial Compass
CompletedPhase 3
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
United States476 participantsStarted 2018-03-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
Efficacy of Avapritinib Based on Progression-free Survival (PFS) Determined by Central Radiological Assessment Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST), Version 1.1
✕. 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