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

January 16, 2026 updated by: Deciphera Pharmaceuticals, LLC

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
453

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Instituto Medicao Especializado Alexander Fleming
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5000JHQ
        • Sanatorio Allende
  • Australia
      • Woolloongabba, Australia
        • Princess Alexandara Hospital
    • New South Wales
      • Albury, New South Wales, Australia
        • Border Medical Oncology Research Unit
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia
        • Princess Alexandra Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre Research
      • Kurralta Park, South Australia, Australia
        • Ashford Cancer Centre Research
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Belgium
      • Brussels, Belgium
        • Institut Jules Bordet
      • Leuven, Belgium
        • UZ Leuven
  • Canada
      • Québec, Canada
        • Hôpital Maisonneuve-Rosemont
    • Alberta
      • Edmonton, Alberta, Canada
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • CancerCare Manitoba
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M5G 2C1
        • Princess Margaret Cancer Centre
  • Chile
      • Santiago, Chile
        • Clinica San Carlos de Apoquindo Red Salud UC Christs
  • Czechia
      • Prague, Czechia
        • Fakultni nemocnice v Motole
  • France
      • Bordeaux, France
        • Institut Bergonnié
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Lille, France
        • Centre Oscar Lambret
      • Lyon, France
        • Centre Léon Bérard
      • Marseille, France
        • Hôpital la Timone
      • Marseille, France
        • IPC
      • Paris, France
        • IGR
      • Poitiers, France
        • CHU Poitiers-Hopital la Miletrie
      • Saint-Herblain, France
        • ICO - Site René Gauducheau
  • Germany
      • Berlin, Germany
        • Helios Klinikum Berlin-Buch
      • Dresden, Germany
        • Technische Universität Dresden
      • Essen, Germany
        • West German Cancer Center
  • Hungary
      • Budapest, Hungary
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Debrecen, Hungary
        • Debreceni Egyetem
  • Israel
      • Be’er Ya‘aqov, Israel
        • Shamir Medical Center (Assaf Harofeh)
      • Petah Tikva, Israel
        • Rabin Medical Cente
      • Tel Aviv, Israel
        • Tel-Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
      • Meldola, Italy
        • stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
      • Milan, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Padua, Italy
        • Iov - Istituto Oncologico Veneto Irccs
      • Palermo, Italy
        • Universita degli Studi di Palermo
      • Rome, Italy
        • Universita Campus Bio-Medico di Roma
  • Netherlands
      • Amsterdam, Netherlands
        • The Netherlands Cancer Institute
      • Amsterdam, Netherlands
        • Antoni van Leeuwenhoek
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Leiden, Netherlands
        • Leiden University Medical Centre
  • Norway
      • Oslo, Norway
        • Oslo University Hospital
  • Poland
      • Warsaw, Poland
        • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre
  • South Korea
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
      • Suwon, South Korea
        • Ajou University Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Bilbao, Spain
        • Hospital de Basurto
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario Clínico San Carlos
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario Hm Madrid Sanchinarro
      • Málaga, Spain
        • Hospital Clínico Universitario Virgen de la Victoria
      • Seville, Spain
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain
        • Instituto Valenciano de Oncología,
      • Vigo, Spain
        • Complejo Hospitalario Universitario de Vigo
  • Sweden
      • Solna, Sweden
        • Karolinska Universitetssjukhuset
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi
      • Zurich, Switzerland
        • Universitaetsspital Zuerich, Klinik fuer Onkologie
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital,
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Chen Kung University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
    • Taoyuan County
      • Linkou District, Taoyuan County, Taiwan
        • Chang Gung Memorial Hospital
  • United Kingdom
      • Glasgow, United Kingdom
        • Beatson West Of Scotland Cancer Centre
      • Leeds, United Kingdom
        • St James's University Hospital
      • London, United Kingdom
        • University College London Hospitals
      • London, United Kingdom
        • Royal Marsden Hospital - Fulham
      • Sheffield, United Kingdom
        • Weston Park Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Scottsdale
    • California
      • La Jolla, California, United States, 92103
        • University of California San Diego Medical Center
      • Los Angeles, California, United States, 90024
        • UCLA Hematology Oncology Center - Main Site
      • Stanford, California, United States, 94305
        • Stanford Medicine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Cancer Pavillion
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Smilow Cancer Hospital at Yale
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Washington Cancer Institute at MedStar Washington Hospital Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute at Baptist Health, Inc.
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center
      • Orlando, Florida, United States, 32806
        • Orlando Health UF Health Cancer Center
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30332
        • Winship Cancer Institute
      • Sandy Springs, Georgia, United States, 30342
        • Georgia Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Iu Simon Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute, Audubon Hospital Campus
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center-Fairview
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine - Siteman Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute
    • New York
      • Buffalo, New York, United States, 43606
        • Roswell Park Cancer Institute
      • Lake Success, New York, United States, 11042
        • The Monter Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center-Montefiore Medical Park
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute
      • Toledo, Ohio, United States, 43606
        • University of Toledo
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Center for Health and Healing
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Henry-Joyce Cancer Clinic
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Massey Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital-Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ripretinib
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Drug: Ripretinib
Oral KIT/PDGFRA kinase inhibitor
Other Names:
  • DCC-2618
Active Comparator: Sunitinib
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Drug: Sunitinib
Oral receptor tyrosine kinase (RTK) inhibitor
Other Names:
  • Sutent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
Progression Free Survival (PFS) in the All Patient (AP) 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)
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.
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
Time Frame: From confirmed CR or PR to disease progression (up to 1.74 years)
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.
From confirmed CR or PR to disease progression (up to 1.74 years)
Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population
Time Frame: From confirmed CR or PR to disease progression (up to 1.74 years)
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.
From confirmed CR or PR to disease progression (up to 1.74 years)
Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population
Time Frame: From date of randomization until death due to any cause (up to 3.33 years)
OS was defined as the time from the date of randomization until death due to any cause.
From date of randomization until death due to any cause (up to 3.33 years)
Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population
Time Frame: From date of randomization until death due to any cause (up to 3.33 years)
OS was defined as the time from the date of randomization until death due to any cause.
From date of randomization until death due to any cause (up to 3.33 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Deciphera Pharmaceuticals, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCC-2618-03-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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