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GISTPhase 3INSIGHTNCT05734105

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

A Phase 3 study testing Ripretinib and Sunitinib in people with GIST, run by Deciphera Pharmaceuticals, LLC at 70 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
GIST
What is being tested?
Ripretinib and Sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
70 sitesin 15 countries
Study dates
13 Dec 2023to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

70 sites in 15 countries.

70 sites in 15 countries

United States20 sites

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Cleveland Clinic

    Cleveland, Ohio, 44195

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

    Columbus, Ohio, 43210

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • Yale University

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

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

    New York, New York, 11042

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Spain8 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario Centra de Asturias

    Oviedo, 33011

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Instituto Valenciano de Oncologia - IVO

    Valencia, Valencia, 46009

  • Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

Italy7 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Nazionale Tumori IRCCS Fondazione "G Pascale"

    Naples, Napoli, 80131

  • Istituto Oncologico Veneto-IOV IRCCS

    Padova, 35128

  • U.O.C. Oncologia Medica

    Palermo, Palermo, 90127

  • Università Campus Bio-Medico di Roma

    Roma, 00128

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

Brazil6 sites

  • Hospital de Cancer de Barretos - Fundacao Pio XII

    Barretos, São Paulo, 14748-400

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

    Florianópolis, Santa Catarina, 88034-000

  • INCA - Instituto Nacional de Cancer

    Rio de Janeiro, Rio de Janeiro, 20231

  • Hospital Sirio-Libanes

    São Paulo, São Paulo, 01308

  • Hospital 9 de Julho

    São Paulo, São Paulo, 01409-002

  • AC Camargo Câncer Center

    São Paulo, São Paulo, 01509-900

Other trials in Brazil

France5 sites

  • Institut Bergonié

    Bordeaux, 33076

  • CHU Dijon

    Dijon, Bourgogone, 21079

  • Centre Léon Bérard

    Lyon, 69373

  • Centre Eugène Marquis

    Rennes, Ille et Vilaine, 35000

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Canada4 sites

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany4 sites

  • Helios Klinikum Berlin-Buch

    Berlin

  • University Hospital Essen (Universitätsklinikum Essen)

    Essen, 45147

  • Heidelberg University Hospital

    Heidelberg, 69120

  • Universitares Krebszentrum Leipzig

    Leipzig, 04103

Other trials in Germany

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Taiwan3 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Australia2 sites

  • Alfred Health

    Melbourne, Victoria, 3004

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

Other trials in Australia

Chile2 sites

  • Clínica San Carlos De Apoquindo Red Salud UC Christus

    Las Condes, RM, 7620002

  • Centro de Oncología de Precisión

    Santiago, RM, 7550000

Other trials in Chile

Netherlands2 sites

  • UMC Groningen

    Groningen, 9713

  • LUMC

    Leiden, 2333 ZA

Other trials in Netherlands

United Kingdom2 sites

  • St. James University Hospital

    Leeds, West Yorkshire, LS9 7TF

  • The Royal Marsden Hospital NHS Foundation Trust

    London, Greater London, SW3 6JJ

Other trials in United Kingdom

Norway1 site

  • Oslo University Hospital

    Oslo, Norway, 0379

Other trials in Norway

Poland1 site

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

    Warsaw, Warszawa, 02-781

Other trials in Poland

About this study

Official title: An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated With Imatinib

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.

Conditions
GIST
Being tested
Ripretinib, Sunitinib
Keywords
advanced gastrointestinal tumors, gastrointestinal stromal tumors, imatinib, ripretinib
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RipretinibDrug

    Also called QINLOCK, DCC-2618

    50 mg tablets

  • SunitinibDrug

    Also called Sutent

    12.5 mg tablets

Study groups in NCT05734105
Study groupRoleWhat they receive
RipretinibExperimental150 mg QD of ripretinib (3×50 mg tablets) will be dosed continuously in repeated 42-day cycles.
Receives: Drug: Ripretinib
SunitinibActive comparator50 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.
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.

    Measured: Up to end of treatment; up to approximately 48 months

Secondary outcomes (2)

  1. Objective Response Rate (ORR)

    Compare ORR by IRR of ripretinib vs sunitinib using mRECIST

    Measured: Up to end of treatment; up to approximately 48 months

  2. Overall Survival (OS)

    Compare OS of ripretinib vs sunitinib

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study start13 Dec 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05734105
Sponsor's protocol ID
DCC-2618-03-003
Other IDs
2022-503058-37-00
Acronym
INSIGHT
Status last verified
Dec 2025
First submitted
8 Feb 2023
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 39229786

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ripretinib and Sunitinib in people with GIST, run by Deciphera Pharmaceuticals, LLC at 70 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Spain, Italy, Brazil, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to end of treatment; up to approximately 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05734105, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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