Comparing ripretinib and sunitinib for advanced GIST with specific mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting

+14 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Team
• Email: Clinicaltrials@deciphera.com
• Phone: 785-830-2100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• KQB198 plus imatinib for first-line advanced or metastatic GIST

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• Oral Liporaxel (paclitaxel) treatment for gastrointestinal stromal tumors

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• Combination of rivoceranib and paclitaxel for advanced gastrointestinal stromal tumors

  This study is testing if a new combination of two drugs, rivoceranib and paclitaxel, can help adults with advanced gastrointestinal stromal tumors that haven't improved with standard treatments.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.