New hope for GIST patients: ripretinib takes on sunitinib in major trial

NCT ID NCT03673501

Disease control Sponsor: Deciphera Pharmaceuticals, LLC Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares two targeted cancer pills, ripretinib and sunitinib, in about 450 people with advanced gastrointestinal stromal tumor (GIST) whose first treatment (imatinib) stopped working or caused side effects. The main goal is to see if ripretinib delays cancer growth better than sunitinib. Patients take one pill daily in cycles, and the study is open-label, meaning everyone knows which drug they receive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ripretinib (a targeted cancer pill) compared to sunitinib (another targeted cancer pill)
What this could lead to: If ripretinib works better, it could become a new standard second-line treatment for advanced GIST, helping patients live longer without their cancer growing.
What could go wrong: This is a late-stage trial, but ripretinib may not prove superior to sunitinib. Both drugs have side effects, and results may not apply to all GIST patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

453 people

The number who actually took part.

Started

Feb 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients ≥ 18 years of age at the time of informed consent. 2. Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required. 3. Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization. 4. Patients must have progressed on imatinib or have documented intolerance to imatinib. 5. Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of ≤ 2 at screening. 6. Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug. 7. Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol. 8. Patients must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 (non nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slice thickness in the long axis) within 21 days prior to the first dose of study drug. 9. Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening. 10. Resolution of all toxicities from prior therapy to ≤ Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities). 11. The patient is capable of understanding and complying with the protocol and the patient has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed and the patient must agree to not participate in any other interventional clinical trial while on treatment in this clinical trial. Participation in a noninterventional study (including observational studies) is permitted. Exclusion Criteria: 1. Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line setting is not allowed. 2. Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. 3. Patient has known active central nervous system metastases. 4. 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. 5. Left ventricular ejection fraction (LVEF) \< 50% at screening. 6. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug. 7. Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible. 8. 12-lead ECG demonstrating QT interval corrected (QTc) by Fridericia's formula \> 450 ms in males or \> 470 ms in females at screening or history of long QTc syndrome 9. Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug. 10. Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug. All major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug. 11. Any other clinically significant comorbidities. 12. Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection. 13. If female, the patient is pregnant or lactating. 14. Known allergy or hypersensitivity to any component of the study drug. 15. Gastrointestinal abnormalities including but not limited to: * inability to take oral medication * malabsorption syndromes * requirement for intravenous (IV) alimentation 16. Any active bleeding excluding hemorrhoidal or gum bleeding.

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Conditions

The condition(s) this trial relates to.

gastrointestinal stromal tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrointestinal stromal tumors

Contacts and locations

Locations

Ajou University Hospital

Suwon, South Korea
Antoni van Leeuwenhoek

Amsterdam, Netherlands
Asan Medical Center

Seoul, South Korea
Ashford Cancer Centre Research

Kurralta Park, South Australia, 5037, Australia
Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Italy
Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom
Border Medical Oncology Research Unit

Albury, New South Wales, Australia
CHU Poitiers-Hopital la Miletrie

Poitiers, France
CancerCare Manitoba

Winnipeg, Manitoba, Canada
Centre Georges François Leclerc

Dijon, France
Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi

Lausanne, Switzerland
Centre Léon Bérard

Lyon, France
Centre Oscar Lambret

Lille, France
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

Warsaw, Poland
Chang Gung Memorial Hospital

Linkou District, Taoyuan County, Taiwan
China Medical University Hospital

Taichung, Taiwan
Clinica San Carlos de Apoquindo Red Salud UC Christs

Santiago, Chile
Complejo Hospitalario Universitario de Vigo

Vigo, Spain
Cross Cancer Institute

Edmonton, Alberta, Canada
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Debreceni Egyetem

Debrecen, Hungary
Duke University Medical Center

Durham, North Carolina, 27710, United States
Fakultni nemocnice v Motole

Prague, Czechia
Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Froedtert Hospital-Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Georgia Cancer Specialists

Sandy Springs, Georgia, 30342, United States
HELIOS Klinikum Berlin-Buch

Berlin, Germany
Henry Ford Health System

Detroit, Michigan, 48202, United States
Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States
Hopital La Timone

Marseille, France
Hopital Maisonneuve-Rosemont

Québec, Canada
Hospital Clinico Universitario Virgen de la Victoria

Málaga, Spain
Hospital Universitari Vall d'Hebron

Barcelona, Spain
Hospital Universitario 12 de Octubre

Madrid, Spain
Hospital Universitario Clinico San Carlos

Madrid, Spain
Hospital Universitario HM Madrid Sanchinarro

Madrid, Spain
Hospital Universitario La Paz

Madrid, Spain
Hospital Universitario Ramon y Cajal

Madrid, Spain
Hospital Universitario Virgen del Rocio

Seville, Spain
Hospital de Basurto

Bilbao, Spain
Hospital de la Santa Creu i Sant Pau

Barcelona, Spain
ICO - Site René Gauducheau

Saint-Herblain, France
IGR

Paris, France
IOV - Istituto Oncologico Veneto IRCCS

Padova, Italy
IPC

Marseille, France
IU Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Institut Bergonnié

Bordeaux, France
Institut Jules Bordet

Brussels, Belgium
Instituto Medicao Especializado Alexander Fleming

Buenos Aires, Argentina
Instituto Valenciano de Oncología,

Valencia, Spain
Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States
Juravinski Cancer Centre

Hamilton, Ontario, Canada
Kaohsiung Chang Gung Memorial Hospital,

Kaohsiung City, Taiwan
Karolinska universitetssjukhuset

Solna, Sweden
Leiden University Medical Centre

Leiden, Netherlands
Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary
Mayo Clinic

Rochester, Minnesota, 55905, United States
Mayo Clinic Florida

Jacksonville, Florida, 32224, United States
Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Montefiore Medical Center-Montefiore Medical Park

The Bronx, New York, 10467, United States
National Cancer Centre

Singapore, 169610, Singapore
National Chen Kung University Hospital

Tainan, Taiwan
Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
Norton Cancer Institute, Audubon Hospital Campus

Louisville, Kentucky, 40241, United States
Oregon Health & Science University Center for Health and Healing

Portland, Oregon, 97239, United States
Orlando Health UF Health Cancer Center

Orlando, Florida, 32806, United States
Oslo University Hospital

Oslo, Norway
Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia
Princess Alexandara Hospital

Woolloongabba, Australia
Princess Alexandra Hospital

Woolloongabba, Queensland, Australia
Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada
Rabin Medical Cente

Petah Tikva, Israel
Rocky Mountain Cancer Centers

Denver, Colorado, 80220, United States
Roswell Park Cancer Institute

Buffalo, New York, 43606, United States
Royal Marsden Hospital - Fulham

London, United Kingdom
Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States
Samsung Medical Center

Seoul, South Korea
Sanatorio Allende

Córdoba, Córdoba Province, X5000JHQ, Argentina
Seoul National University Hospital

Seoul, South Korea
Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, Israel
Smilow Cancer Hospital at Yale

New Haven, Connecticut, 06511, United States
St James's University Hospital

Leeds, United Kingdom
Stanford Medicine

Stanford, California, 94305, United States
Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States
Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States
Taipei Veterans General Hospital

Taipei, Taiwan
Technische Universitat Dresden

Dresden, Germany
Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel
Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
The Monter Cancer Center

Lake Success, New York, 11042, United States
The Netherlands Cancer Institute

Amsterdam, Netherlands
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute

Columbus, Ohio, 43210, United States
The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada
UCLA Hematology Oncology Center - Main Site

Los Angeles, California, 90024, United States
UZ Leuven

Leuven, Belgium
Universita degli Studi di Palermo

Palermo, Italy
Universitaetsspital Zuerich, Klinik fuer Onkologie

Zurich, Switzerland
University College London Hospitals

London, United Kingdom
University Medical Center Groningen

Groningen, Netherlands
University of California San Diego Medical Center

La Jolla, California, 92103, United States
University of Chicago Medical Center

Chicago, Illinois, 60637, United States
University of Colorado Hospital - Anschutz Cancer Pavillion

Aurora, Colorado, 80045, United States
University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States
University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, 55455, United States
University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
University of Toledo

Toledo, Ohio, 43606, United States
University of Washington Medical Center

Seattle, Washington, 98195, United States
Università Campus Bio-Medico di Roma

Rome, Italy
Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States
Washington Cancer Institute at MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States
West German Cancer Center

Essen, Germany
Weston Park Hospital

Sheffield, United Kingdom
Winship Cancer Institute

Atlanta, Georgia, 30332, United States
stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

Meldola, Italy

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