At a glance
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A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib
In Brief
A Phase 3 clinical trial evaluating Ripretinib and Sunitinib for Gastrointestinal Stromal Tumors. Active but no longer recruiting, targeting 453 participants across 121 sites in 22 countries.
Detailed Summary
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).
Study Details
Timeline
Interventions
Oral KIT/PDGFRA kinase inhibitor
Oral receptor tyrosine kinase (RTK) inhibitor