A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
NCT ID: NCT05734105
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
54 participants
INTERVENTIONAL
2023-12-13
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ripretinib
150 mg QD of ripretinib (3×50 mg tablets) will be dosed continuously in repeated 42-day cycles.
Ripretinib
50 mg tablets
Sunitinib
50 mg QD of sunitinib (4×12.5 mg capsules) will be dosed in 42-day cycles. Sunitinib will be given continuously for 4 weeks with a 2-week break.
Sunitinib
12.5 mg tablets
Interventions
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Ripretinib
50 mg tablets
Sunitinib
12.5 mg tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Deciphera Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team
Role: STUDY_DIRECTOR
Deciphera Pharmaceuticals, LLC
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
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
Hospital Sirio-Libanes
São Paulo, São Paulo, Brazil
Hospital 9 de Julho
São Paulo, São Paulo, Brazil
AC Camargo Câncer Center
São Paulo, São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Clínica San Carlos De Apoquindo Red Salud UC Christus
Las Condes, RM, Chile
Centro de Oncología de Precisión
Santiago, RM, Chile
CHU Dijon
Dijon, Bourgogone, France
Centre Eugène Marquis
Rennes, Ille et Vilaine, France
Institut Bergonié
Bordeaux, , France
Centre Léon Bérard
Lyon, , France
Institut Gustave Roussy
Villejuif, , France
Helios Klinikum Berlin-Buch
Berlin, , Germany
University Hospital Essen (Universitätsklinikum Essen)
Essen, , Germany
Heidelberg University Hospital
Heidelberg, , Germany
Universitares Krebszentrum Leipzig
Leipzig, , Germany
Istituto Nazionale Tumori IRCCS Fondazione "G Pascale"
Naples, Napoli, Italy
U.O.C. Oncologia Medica
Palermo, Palermo, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Oncologico Veneto-IOV IRCCS
Padua, , Italy
Università Campus Bio-Medico di Roma
Roma, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
UMC Groningen
Groningen, , Netherlands
LUMC
Leiden, , Netherlands
Oslo University Hospital
Oslo, Norway, Norway
Narodowy Instytut Onkologii Im . Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Warszawa, Poland
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, Spain
Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Instituto Valenciano de Oncologia - IVO
Valencia, Valencia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Centra de Asturias
Oviedo, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
The Royal Marsden Hospital NHS Foundation Trust
London, Greater London, United Kingdom
St. James University Hospital
Leeds, West Yorkshire, United Kingdom
Countries
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References
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George S, Blay JY, Chi P, Jones RL, Serrano C, Somaiah N, Gelderblom H, Zalcberg JR, Reichmann W, Sprott K, Cox P, Sherman ML, Ruiz-Soto R, Heinrich MC, Bauer S. The INSIGHT study: a randomized, Phase III study of ripretinib versus sunitinib for advanced gastrointestinal stromal tumor with KIT exon 11 + 17/18 mutations. Future Oncol. 2024;20(27):1973-1982. doi: 10.1080/14796694.2024.2376521. Epub 2024 Sep 4.
Related Links
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INSIGHT Patient Website
INSIGHT Physician Website
Other Identifiers
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2022-503058-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
DCC-2618-03-003
Identifier Type: -
Identifier Source: org_study_id