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ACTIVE NOT RECRUITING
NCT05734105
PHASE3

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

Sponsor: Deciphera Pharmaceuticals, LLC

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2023-12-13

Completion Date

2028-12

Last Updated

2025-12-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ripretinib

50 mg tablets

DRUG

Sunitinib

12.5 mg tablets

Locations (70)

UC San Diego Moores Cancer Center

La Jolla, California, United States

Yale University

New Haven, Connecticut, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

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

Columbus, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Prince of Wales Hospital

Randwick, New South Wales, Australia

Alfred Health

Melbourne, Victoria, Australia

INCA - Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, Brazil

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

Florianópolis, Santa Catarina, Brazil

Hospital de Cancer de Barretos - Fundacao Pio XII

Barretos, São Paulo, Brazil

Hospital Sirio-Libanes

São Paulo, São Paulo, Brazil

Hospital 9 de Julho

São Paulo, São Paulo, Brazil

AC Camargo Câncer Center

São Paulo, São Paulo, Brazil

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Clínica San Carlos De Apoquindo Red Salud UC Christus

Las Condes, RM, Chile

Centro de Oncología de Precisión

Santiago, RM, Chile

CHU Dijon

Dijon, Bourgogone, France

Centre Eugène Marquis

Rennes, Ille et Vilaine, France

Institut Bergonié

Bordeaux, France

Centre Léon Bérard

Lyon, France

Institut Gustave Roussy

Villejuif, France

Helios Klinikum Berlin-Buch

Berlin, Germany

University Hospital Essen (Universitätsklinikum Essen)

Essen, Germany

Heidelberg University Hospital

Heidelberg, Germany

Universitares Krebszentrum Leipzig

Leipzig, Germany

Istituto Nazionale Tumori IRCCS Fondazione "G Pascale"

Naples, Napoli, Italy

U.O.C. Oncologia Medica

Palermo, Palermo, Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Istituto Oncologico Veneto-IOV IRCCS

Padova, Italy

Università Campus Bio-Medico di Roma

Roma, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

UMC Groningen

Groningen, Netherlands

LUMC

Leiden, Netherlands

Oslo University Hospital

Oslo, Norway, Norway

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

Warsaw, Warszawa, Poland

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, Spain

Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Instituto Valenciano de Oncologia - IVO

Valencia, Valencia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Centra de Asturias

Oviedo, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

The Royal Marsden Hospital NHS Foundation Trust

London, Greater London, United Kingdom

St. James University Hospital

Leeds, West Yorkshire, United Kingdom