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ACTIVE NOT RECRUITING
NCT03673501
PHASE3

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

Sponsor: Deciphera Pharmaceuticals, LLC

View on ClinicalTrials.gov

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. 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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

453

Start Date

2019-02-08

Completion Date

2026-12

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

Ripretinib

Oral KIT/PDGFRA kinase inhibitor

DRUG

Sunitinib

Oral receptor tyrosine kinase (RTK) inhibitor

Locations (121)

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

University of California San Diego Medical Center

La Jolla, California, United States

UCLA Hematology Oncology Center - Main Site

Los Angeles, California, United States

Stanford Medicine

Stanford, California, United States

University of Colorado Hospital - Anschutz Cancer Pavillion

Aurora, Colorado, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Smilow Cancer Hospital at Yale

New Haven, Connecticut, United States

Washington Cancer Institute at MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

Orlando Health UF Health Cancer Center

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Georgia Cancer Specialists

Sandy Springs, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

IU Simon Cancer Center

Indianapolis, Indiana, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Norton Cancer Institute, Audubon Hospital Campus

Louisville, Kentucky, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

The Monter Cancer Center

Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center-Montefiore Medical Park

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

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

Columbus, Ohio, United States

University of Toledo

Toledo, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University Center for Health and Healing

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

Froedtert Hospital-Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Sanatorio Allende

Córdoba, Córdoba Province, Argentina

Instituto Medicao Especializado Alexander Fleming

Buenos Aires, Argentina

Border Medical Oncology Research Unit

Albury, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Princess Alexandara Hospital

Woolloongabba, Australia

Institut Jules Bordet

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Cross Cancer Institute

Edmonton, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont

Québec, Canada

Clinica San Carlos de Apoquindo Red Salud UC Christs

Santiago, Chile

Fakultni nemocnice v Motole

Prague, Czechia

Institut Bergonnié

Bordeaux, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Centre Léon Bérard

Lyon, France

Hopital La Timone

Marseille, France

IPC

Marseille, France

IGR

Paris, France

CHU Poitiers-Hopital la Miletrie

Poitiers, France

ICO - Site René Gauducheau

Saint-Herblain, France

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Technische Universitat Dresden

Dresden, Germany

West German Cancer Center

Essen, Germany

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary

Debreceni Egyetem

Debrecen, Hungary

Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, Israel

Rabin Medical Cente

Petah Tikva, Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Italy

stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

Meldola, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

IOV - Istituto Oncologico Veneto IRCCS

Padova, Italy

Universita degli Studi di Palermo

Palermo, Italy

Università Campus Bio-Medico di Roma

Rome, Italy

Antoni van Leeuwenhoek

Amsterdam, Netherlands

The Netherlands Cancer Institute

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Centre

Leiden, Netherlands

Oslo University Hospital

Oslo, Norway

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

Warsaw, Poland

National Cancer Centre

Singapore, Singapore

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital de Basurto

Bilbao, 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 Clinico Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Instituto Valenciano de Oncología,

Valencia, Spain

Complejo Hospitalario Universitario de Vigo

Vigo, Spain

Karolinska universitetssjukhuset

Solna, Sweden

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

Lausanne, Switzerland

Universitaetsspital Zuerich, Klinik fuer Onkologie

Zurich, Switzerland

Chang Gung Memorial Hospital

Linkou District, Taoyuan County, Taiwan

Kaohsiung Chang Gung Memorial Hospital,

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Chen Kung University Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

St James's University Hospital

Leeds, United Kingdom

Royal Marsden Hospital - Fulham

London, United Kingdom

University College London Hospitals

London, United Kingdom

Weston Park Hospital

Sheffield, United Kingdom