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Gastrointestinal Stromal TumorsPhase 3INTRIGUENCT03673501

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

A Phase 3 study testing Ripretinib and Sunitinib in people with Gastrointestinal Stromal Tumors, run by Deciphera Pharmaceuticals, LLC at 121 sites in 22 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 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumors
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
453 participants
Where
121 sitesin 22 countries
Study dates
8 Feb 2019to Dec 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients ≥ 18 years of age at the time of informed consent.
  • Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
  • 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.
  • Patients must have progressed on imatinib or have documented intolerance to imatinib.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of ≤ 2 at screening.
  • 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.
Show all 11Show fewer
  • Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
  • 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.
  • Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
  • 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).
  • 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.

Who cannot join

  • 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.
  • 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.
  • Patient 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.
  • Left ventricular ejection fraction (LVEF) < 50% at screening.
  • Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
Show all 19Show fewer
  • 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.
  • 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
  • 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.
  • 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.
  • Any other clinically significant comorbidities.
  • 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.
  • If female, the patient is pregnant or lactating.
  • Known allergy or hypersensitivity to any component of the study drug.
  • Gastrointestinal abnormalities including but not limited to:
  • inability to take oral medication
  • malabsorption syndromes
  • requirement for intravenous (IV) alimentation
  • Any active bleeding excluding hemorrhoidal or gum bleeding.

Trial locations and contacts

121 sites in 22 countries.

121 sites in 22 countries

United States43 sites

  • Winship Cancer Institute

    Atlanta, Georgia, 30332

  • University of Colorado Hospital - Anschutz Cancer Pavillion

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 43606

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

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

    Columbus, Ohio, 43210

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • IU Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • University of California San Diego Medical Center

    La Jolla, California, 92103

  • The Monter Cancer Center

    Lake Success, New York, 11042

  • UCLA Hematology Oncology Center - Main Site

    Los Angeles, California, 90024

  • Norton Cancer Institute, Audubon Hospital Campus

    Louisville, Kentucky, 40241

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • Froedtert Hospital-Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Medical Center-Fairview

    Minneapolis, Minnesota, 55455

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901

  • Smilow Cancer Hospital at Yale

    New Haven, Connecticut, 06511

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Orlando Health UF Health Cancer Center

    Orlando, Florida, 32806

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Oregon Health & Science University Center for Health and Healing

    Portland, Oregon, 97239

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Georgia Cancer Specialists

    Sandy Springs, Georgia, 30342

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110

  • Stanford Medicine

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center-Montefiore Medical Park

    The Bronx, New York, 10467

  • University of Toledo

    Toledo, Ohio, 43606

  • Washington Cancer Institute at MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Spain12 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital de Basurto

    Bilbao

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Clinico San Carlos

    Madrid

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga

  • Hospital Universitario Virgen del Rocio

    Seville

  • Instituto Valenciano de Oncología,

    Valencia

  • Complejo Hospitalario Universitario de Vigo

    Vigo

Other trials in Spain

France9 sites

  • Institut Bergonnié

    Bordeaux

  • Centre Georges François Leclerc

    Dijon

  • Centre Oscar Lambret

    Lille

  • Centre Léon Bérard

    Lyon

  • Hopital La Timone

    Marseille

  • IPC

    Marseille

  • IGR

    Paris

  • CHU Poitiers-Hopital la Miletrie

    Poitiers

  • ICO - Site René Gauducheau

    Saint-Herblain

Other trials in France

Australia7 sites

  • Border Medical Oncology Research Unit

    Albury, New South Wales

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

  • Princess Alexandara Hospital

    Woolloongabba

Other trials in Australia

Canada6 sites

  • Cross Cancer Institute

    Edmonton, Alberta

  • Juravinski Cancer Centre

    Hamilton, Ontario

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario

  • Hopital Maisonneuve-Rosemont

    Québec

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1

  • CancerCare Manitoba

    Winnipeg, Manitoba

Other trials in Canada

Italy6 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna

  • stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

    Meldola

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova

  • Universita degli Studi di Palermo

    Palermo

  • Università Campus Bio-Medico di Roma

    Rome

Other trials in Italy

Taiwan5 sites

  • Kaohsiung Chang Gung Memorial Hospital,

    Kaohsiung City

  • Chang Gung Memorial Hospital

    Linkou District, Taoyuan County

  • China Medical University Hospital

    Taichung

  • National Chen Kung University Hospital

    Tainan

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

United Kingdom5 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • St James's University Hospital

    Leeds

  • Royal Marsden Hospital - Fulham

    London

  • University College London Hospitals

    London

  • Weston Park Hospital

    Sheffield

Other trials in United Kingdom

Netherlands4 sites

  • Antoni van Leeuwenhoek

    Amsterdam

  • The Netherlands Cancer Institute

    Amsterdam

  • University Medical Center Groningen

    Groningen

  • Leiden University Medical Centre

    Leiden

Other trials in Netherlands

South Korea4 sites

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Germany3 sites

  • HELIOS Klinikum Berlin-Buch

    Berlin

  • Technische Universitat Dresden

    Dresden

  • West German Cancer Center

    Essen

Other trials in Germany

Israel3 sites

  • Shamir Medical Center (Assaf Harofeh)

    Be’er Ya‘aqov

  • Rabin Medical Cente

    Petah Tikva

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Argentina2 sites

  • Instituto Medicao Especializado Alexander Fleming

    Buenos Aires

  • Sanatorio Allende

    Córdoba, Córdoba Province, X5000JHQ

Other trials in Argentina

Belgium2 sites

  • Institut Jules Bordet

    Brussels

  • UZ Leuven

    Leuven

Other trials in Belgium

Hungary2 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest

  • Debreceni Egyetem

    Debrecen

Other trials in Hungary

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi

    Lausanne

  • Universitaetsspital Zuerich, Klinik fuer Onkologie

    Zurich

Other trials in Switzerland

Chile1 site

  • Clinica San Carlos de Apoquindo Red Salud UC Christs

    Santiago

Other trials in Chile

Czechia1 site

  • Fakultni nemocnice v Motole

    Prague

Other trials in Czechia

Norway1 site

  • Oslo University Hospital

    Oslo

Other trials in Norway

Poland1 site

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw

Other trials in Poland

Singapore1 site

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

Sweden1 site

  • Karolinska universitetssjukhuset

    Solna

Other trials in Sweden

About this study

Official title: A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib

This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).

Being tested
Ripretinib, Sunitinib
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 DCC-2618

    Oral KIT/PDGFRA kinase inhibitor

  • SunitinibDrug

    Also called Sutent

    Oral receptor tyrosine kinase (RTK) inhibitor

Study groups in NCT03673501
Study groupRoleWhat they receive
RipretinibExperimentalRipretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Receives: Drug: Ripretinib
SunitinibActive comparatorSunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 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) in the KIT Exon 11 Intent to Treat (ITT) Population

    PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)

  2. Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population

    PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)

Secondary outcomes (4)

  1. Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population

    ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as >=30% decrease in the sum of the longest diameter of target lesions.

    Measured: From confirmed CR or PR to disease progression (up to 1.74 years)

  2. Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population

    ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as >=30% decrease in the sum of the longest diameter of target lesions.

    Measured: From confirmed CR or PR to disease progression (up to 1.74 years)

  3. Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population

    OS was defined as the time from the date of randomization until death due to any cause.

    Measured: From date of randomization until death due to any cause (up to 3.33 years)

  4. Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population

    OS was defined as the time from the date of randomization until death due to any cause.

    Measured: From date of randomization until death due to any cause (up to 3.33 years)

Timeline

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

  1. First posted17 Sep 2018
  2. Study start8 Feb 2019
  3. Primary completion1 Sep 2021
  4. Study completionDec 2027 (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
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03673501
Sponsor's protocol ID
DCC-2618-03-002
Acronym
INTRIGUE
Status last verified
Sep 2026
First submitted
13 Sep 2018
Last updated
16 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heinrich MC, Blay JY, Gelderblom H, George S, Schoffski P, von Mehren M, Zalcberg JR, Jones RL, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Boye K, Goldstein D, Sanchez C, Siontis BL, Cox P, Davis E, Sherman ML, Ruiz-Soto R, Bauer S. Updated Overall Survival and Long-Term Safety With Ripretinib Versus Sunitinib in Patients With GI Stromal Tumor: Final Overall Survival Analysis From INTRIGUE. J Clin Oncol. 2025 Jul 10;43(20):2239-2244. doi: 10.1200/JCO-24-02818. Epub 2025 May 23.

    PubMed 40408605

  • Heinrich MC, Jones RL, George S, Gelderblom H, Schoffski P, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Siontis BL, Goldstein D, Boye K, Sanchez C, Steeghs N, Rutkowski P, Druta M, Serrano C, Somaiah N, Chi P, Reichmann W, Sprott K, Achour H, Sherman ML, Ruiz-Soto R, Blay JY, Bauer S. Ripretinib versus sunitinib in gastrointestinal stromal tumor: ctDNA biomarker analysis of the phase 3 INTRIGUE trial. Nat Med. 2024 Feb;30(2):498-506. doi: 10.1038/s41591-023-02734-5. Epub 2024 Jan 5.

    PubMed 38182785

  • Gelderblom H, Jones RL, Blay JY, George S, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Siontis BL, Goldstein D, Boye K, Sanchez C, Steeghs N, Rutkowski P, Druta M, Serrano C, Somaiah N, Chi P, Harrow B, Becker C, Reichmann W, Sherman ML, Ruiz-Soto R, Heinrich MC, Bauer S; INTRIGUE investigators. Patient-reported outcomes and tolerability in patients receiving ripretinib versus sunitinib after treatment with imatinib in INTRIGUE, a phase 3, open-label study. Eur J Cancer. 2023 Oct;192:113245. doi: 10.1016/j.ejca.2023.113245. Epub 2023 Jul 20.

    PubMed 37598656

  • Bauer S, Jones RL, Blay JY, Gelderblom H, George S, Schoffski P, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Su Y, Meade J, Wang T, Sherman ML, Ruiz-Soto R, Heinrich MC. Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Dec 1;40(34):3918-3928. doi: 10.1200/JCO.22.00294. Epub 2022 Aug 10.

    PubMed 35947817

  • Nemunaitis J, Bauer S, Blay JY, Choucair K, Gelderblom H, George S, Schoffski P, Mehren MV, Zalcberg J, Achour H, Ruiz-Soto R, Heinrich MC. Intrigue: Phase III study of ripretinib versus sunitinib in advanced gastrointestinal stromal tumor after imatinib. Future Oncol. 2020 Jan;16(1):4251-4264. doi: 10.2217/fon-2019-0633. Epub 2019 Nov 22.

    PubMed 31755321

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ripretinib and Sunitinib in people with Gastrointestinal Stromal Tumors, run by Deciphera Pharmaceuticals, LLC at 121 sites in 22 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 11 inclusion and 19 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, Spain, France, Australia, Canada and 17 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?

Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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) in the KIT Exon 11 Intent to Treat (ITT) Population (time frame: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)). The study lists 2 primary outcomes in all. 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 NCT03673501, which also lists 5 linked publications.

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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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