Home › Trials › NCT05734105

Comparing ripretinib and sunitinib for advanced GIST with specific mutations

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

Phase 3 Interventional Deciphera Pharmaceuticals, LLC · NCT05734105

This study is testing whether the drug ripretinib works better than sunitinib for people with advanced gastrointestinal stromal tumors that have certain mutations and who have already been treated with another medication.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment54 (estimated)
Ages18 Years and up
SexAll
SponsorDeciphera Pharmaceuticals, LLC Industry-sponsored
Drugs / interventionsimatinib, ripretinib, sunitinib
Locations64 sites (La Jolla, California and 63 other locations)
Trial IDNCT05734105 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter trial evaluates the effectiveness of ripretinib versus sunitinib in patients with advanced gastrointestinal stromal tumors (GIST) who have specific KIT exon mutations and have previously been treated with imatinib. Participants will be randomized to receive either ripretinib or sunitinib, and those on sunitinib who experience disease progression will have the option to switch to ripretinib. The study aims to determine which treatment provides better outcomes for patients with these specific genetic profiles.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced GIST and specific KIT exon mutations who have progressed on imatinib treatment.

Not a fit: Patients with a history of KIT exon 9 mutations or those with active central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with advanced GIST who have specific KIT mutations.

How similar studies have performed: Previous studies have shown promising results with targeted therapies in GIST, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample.
3. Participants must have advanced GIST and radiologic progression on imatinib treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
5. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug.
6. Participants of reproductive potential must agree to follow contraception requirements.
7. Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug.
8. Adequate organ function and bone marrow reserve based on laboratory assessments performed at screening.

Exclusion Criteria:

1. History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample.
2. Has known active central nervous system metastases.
3. New York Heart Association Class II-IV heart disease, myocardial infarction within 6 months of Cycle 1 Day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure.
4. Use of strong or moderate inhibitors or inducers of cytochrome P450 (CYP) 3A prior to the first dose of study drug, and consumption of grapefruit or grapefruit juice within 14 days prior to the first dose of study drug.
5. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
6. Known human immunodeficiency virus or hepatitis C infection only if the participant is taking medications that are excluded per protocol, acute or chronic hepatitis B, or acute or chronic hepatitis C infection.
7. Gastrointestinal abnormalities including, but not limited to:

   1. inability to take oral medication
   2. malabsorption syndromes
   3. requirement for intravenous alimentation
8. Any active bleeding excluding hemorrhoidal or gum bleeding.

Where this trial is running

La Jolla, California and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GISTadvanced gastrointestinal tumorsgastrointestinal stromal tumorsimatinibripretinib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.