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A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
NCT05734105 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Sunitinib
- DRUG Ripretinib
Study Locations (20)
Florida
- Mayo Clinic Florida — Jacksonville
- Sylvester Comprehensive Cancer Center — Miami
- Moffitt Cancer Center — Tampa
Massachusetts
- Boston Medical Center — Boston
- Dana-Farber Cancer Institute — Boston
Minnesota
- M Health Fairview University of Minnesota Medical Center — Minneapolis
- Mayo Clinic — Rochester
New York
- Memorial Sloan Kettering Cancer Center — New York
- Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center — New York
Ohio
- Cleveland Clinic — Cleveland
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus
California
- UC San Diego Moores Cancer Center — La Jolla
Connecticut
- Yale University — New Haven
Maryland
- Johns Hopkins Hospital — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05734105
The ClinicalTrials.gov registry entry for NCT05734105 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Deciphera Pharmaceuticals, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with GIST appearing as the primary indexed condition, and to 2 interventions — of which Sunitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05734105 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, Massachusetts, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05734105 about?
NCT05734105 is a clinical study titled "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 mutati...
What is the current status of trial NCT05734105?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2023-12-13. Estimated completion is 2028-12.
What conditions does trial NCT05734105 study?
This clinical trial studies the following conditions: GIST. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05734105?
The interventions under investigation include: Sunitinib (DRUG), Ripretinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05734105?
This trial is sponsored by Deciphera Pharmaceuticals, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05734105 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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