A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

NCT Number	NCT05734105
Lead Sponsor	Deciphera Pharmaceuticals, LLC
Conditions	GIST
Enrollment	54 participants
Start Date	2023-12-13
Primary Completion	2027-12 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-17