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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
Trial Status: active
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.
Inclusion Criteria
Male or female ≥18 years of age.
Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample.
Participants must have advanced GIST and radiologic progression on imatinib treatment.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug.
Participants of reproductive potential must agree to follow contraception requirements.
Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug.
Adequate organ function and bone marrow reserve based on laboratory assessments performed at screening.
Exclusion Criteria
History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample.
Has known active central nervous system metastases.
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.
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.
Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
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.
Gastrointestinal abnormalities including, but not limited to:
inability to take oral medication
malabsorption syndromes
requirement for intravenous alimentation
Any active bleeding excluding hemorrhoidal or gum bleeding.
Additional locations may be listed on ClinicalTrials.gov for NCT05734105.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
North Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
