NCT05734105

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

An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated With Imatinib

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Deciphera Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• GIST

Interventions

Type	Name	Description
DRUG	Ripretinib	50 mg tablets
DRUG	Sunitinib	12.5 mg tablets

Timeline

• Start date: 2023-12-13
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2023-02-17
• Last updated: 2025-12-17

Locations

70 sites across 15 countries: United States, Australia, Brazil, Canada, Chile, France, Germany, Italy, Netherlands, Norway, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study