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New hope for rare stomach cancer: drug combo targets tough mutations

NCT ID NCT05734105

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two drugs, ripretinib and sunitinib, in people with advanced gastrointestinal stromal tumors (GIST) that have specific genetic changes (KIT exon 11 plus 17/18 mutations) and have stopped responding to the first treatment, imatinib. About 54 participants will be randomly assigned to receive either ripretinib or sunitinib to see which one better delays cancer growth. If the cancer worsens on sunitinib, those patients may switch to ripretinib.

What this could mean

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

Active substance
Ripretinib (QINLOCK) and Sunitinib (Sutent)
What this could lead to
If ripretinib works better than sunitinib, it could become a new standard second-line treatment for people with this specific type of advanced GIST.
What could go wrong
This is a relatively small Phase 3 trial (54 participants) and results may not apply to all GIST patients. There is no guarantee ripretinib will prove superior or be approved for this use.

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

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2028

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. 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.

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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.

GIST

Contacts and locations

Locations

  • AC Camargo Câncer Center

    São Paulo, São Paulo, 01509-900, Brazil

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138, Italy

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CEPEN - Centro de Pesquisa e Ensino em Saude de Santa Catarina

    Florianópolis, Santa Catarina, 88034-000, Brazil

  • CHU Dijon

    Dijon, Bourgogone, 21079, France

  • Centre Eugène Marquis

    Rennes, Ille et Vilaine, 35000, France

  • Centre Léon Bérard

    Lyon, 69373, France

  • Centro de Oncología de Precisión

    Santiago, RM, 7550000, Chile

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clínica San Carlos De Apoquindo Red Salud UC Christus

    Las Condes, RM, 7620002, Chile

  • Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36312, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Heidelberg University Hospital

    Heidelberg, 69120, Germany

  • Helios Klinikum Berlin-Buch

    Berlin, Germany

  • Hospital 9 de Julho

    São Paulo, São Paulo, 01409-002, Brazil

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Sirio-Libanes

    São Paulo, São Paulo, 01308, Brazil

  • Hospital Universitario Centra de Asturias

    Oviedo, 33011, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de Cancer de Barretos - Fundacao Pio XII

    Barretos, São Paulo, 14748-400, Brazil

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • INCA - Instituto Nacional de Cancer

    Rio de Janeiro, Rio de Janeiro, 20231, Brazil

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto Valenciano de Oncologia - IVO

    Valencia, Valencia, 46009, Spain

  • Istituto Nazionale Tumori IRCCS Fondazione "G Pascale"

    Naples, Napoli, 80131, Italy

  • Istituto Oncologico Veneto-IOV IRCCS

    Padova, 35128, Italy

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

  • LUMC

    Leiden, 2333 ZA, Netherlands

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Narodowy Instytut Onkologii Im . Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, Warszawa, 02-781, Poland

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center

    New York, New York, 11042, United States

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Oslo University Hospital

    Oslo, Norway, 0379, Norway

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • St. James University Hospital

    Leeds, West Yorkshire, LS9 7TF, United Kingdom

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • The Royal Marsden Hospital NHS Foundation Trust

    London, Greater London, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • U.O.C. Oncologia Medica

    Palermo, Palermo, 90127, Italy

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • UMC Groningen

    Groningen, 9713, Netherlands

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitares Krebszentrum Leipzig

    Leipzig, 04103, Germany

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospital Essen (Universitätsklinikum Essen)

    Essen, 45147, Germany

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Università Campus Bio-Medico di Roma

    Roma, 00128, Italy

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.