A Phase 3 interventional study of Ripretinib and Sunitinib in GIST, sponsored by Deciphera Pharmaceuticals, LLC. Active, not recruiting at 70 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Deciphera Pharmaceuticals, LLC · Phase 3, Interventional, and Treatment
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.
333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.
This study's planned enrollment of 54 is close to the median of 50 across 243 interventional studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →Deciphera Pharmaceuticals, LLC is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gastrointestinal abnormalities including, but not limited to:
150 mg QD of ripretinib (3×50 mg tablets) will be dosed continuously in repeated 42-day cycles.
Drug: Ripretinib
50 mg QD of sunitinib (4×12.5 mg capsules) will be dosed in 42-day cycles. Sunitinib will be given continuously for 4 weeks with a 2-week break.
Drug: Sunitinib
50 mg tablets
Also known as: QINLOCK, DCC-2618
12.5 mg tablets
Also known as: Sutent
Progression-free Survival (PFS)
The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.
Time frame: Up to end of treatment; up to approximately 48 months
Objective Response Rate (ORR)
Compare ORR by IRR of ripretinib vs sunitinib using mRECIST
Time frame: Up to end of treatment; up to approximately 48 months
Overall Survival (OS)
Compare OS of ripretinib vs sunitinib
Time frame: Up to approximately 48 months
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Gastrointestinal Stromal Tumors→
Deciphera Pharmaceuticals, LLC