A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

Running, not enrolling · Phase 3

Conditions studied: GIST

In brief

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.

Key facts

Study ID

NCT05734105

Run by

Deciphera Pharmaceuticals, LLC

People needed

54

Starts

2023-12-13

Expected to finish

2028-12-01

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale University — New Haven, Connecticut, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Prince of Wales Hospital — Randwick, New South Wales, Australia
• Alfred Health — Melbourne, Victoria, Australia
• INCA - Instituto Nacional de Cancer — Rio de Janeiro, Rio de Janeiro, Brazil
• CEPEN - Centro de Pesquisa e Ensino em Saude de Santa Catarina — Florianópolis, Santa Catarina, Brazil
• Hospital de Cancer de Barretos - Fundacao Pio XII — Barretos, São Paulo, Brazil
• UC San Diego Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.