An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)
Who is this study for? Patients with Gastrointestinal Stromal Tumors
Status: Completed
Location: See all (112) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients who are ≥ 18 years of age.
• Patients who have histologically confirmed metastatic or unresectable GIST.
• Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment onto BLU-285-1303 study.
• Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
Locations
United States
Arizona
Mayo Clinic Cancer Center
Phoenix
California
UCLA Hematology/Oncology - Santa Monica
Santa Monica
Colorado
University of Colorado Hospital
Aurora
Rocky Mountain Cancer Centers
Boulder
Washington, D.c.
Washington Hospital Center - Oncology and Hematology
Washington
Florida
Mayo Clinic Cancer Center
Jacksonville
University of Miami
Miami
Moffitt Cancer Center
Tampa
Georgia
Northside Hospital
Atlanta
Illinois
Northwestern Medicine
Chicago
The University of Chicago Medical Center
Chicago
Massachusetts
Dana Farber Cancer Institute
Boston
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Minnesota
Mayo Clinic Cancer Center
Rochester
Missouri
Washington University in Saint Louis
Saint Louis
North Carolina
Duke University Medical Center
Durham
New York
Memorial Sloan Kettering Cancer Center
New York
Ohio
Ohio State University
Columbus
Oregon
OHSU - Knight Cancer Institute
Portland
Pennsylvania
Fox Chase Cancer Center
Philadelphia
UPMC Hillman Cancer Center
Pittsburgh
Tennessee
Tennessee Oncology
Nashville
Texas
USO - Texas Oncology
Dallas
Texas Oncology - Denton South
Denton
University of Texas MD Anderson
Houston
Texas Oncology - Waco
Waco
Utah
Huntsman Cancer Institute
Salt Lake City
Washington
Fred Hutchinson Cancer Research Center
Seattle
Summit Cancer Centers
Spokane
Wisconsin
Medical College of Wisconsin - Froedtert Hospital
Milwaukee
Other Locations
Australia
Flinders Medical Center
Adelaide
Monash Health
Clayton
The Canberra Hospital
Garran
Austria
AKH, Klinik f. Innere Med. I, Onkologie
Wien
Belgium
Institut Jules Bordet
Brussels
Leuven Cancer Institute
Leuven
Canada
Cross Cancer Institute
Edmonton
Jewish General Hospital
Montréal
University Health Network
Toronto
China
Beijing Cancer Hospital
Beijing
Chinese PLA General Hospital
Beijing
West China Hospital Sichuan University
Chengdu
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Fujian Medical University Union Hospital
Fuzhou
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou
The First Affiliated Hospital, Zhejiang University
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
The First Affiliated Hospital of Nanchang Medical University
Nanchang
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
Nanning
The Affiliated Hospital of Qingdao University
Qingdao
Fudan University Shanghai Cancer Center
Shanghai
Fudan University Zhongshan Hospital
Shanghai
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai
Liaoning Cancer Hospital & Institute
Shenyang
Tianjin Cancer Hospital
Tianjin
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
France
Institut Bergonié
Bordeaux
Centre Oscar Lambret
Lille
UNICANCER - Lyon, Centre Léon-Bérard
Lyon
Institute Paoli Calmettes
Marseille
La Timone University Hospital
Marseille
Institut Curie
Paris
Centre Rene Gauducheau
Saint-herblain
Gustave Roussy Cancer Campus
Villejuif
Germany
HELIOS Klinikum Bad Saarow
Bad Saarow
HELIOS Klinikum Berlin-Buch
Berlin
Medizinische Fakultät Carl Gustav Carus
Dresden
Universitaetsklindum Essen
Essen
Universitätsklinikum Frankfurt
Frankfurt
Studienzentrale GbR Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt
Lubeck
Rupercht-Karls-Universitaet Heidelberg
Mannheim
Hungary
Fovarosi Onkormanyzat Szent Laszlo Korhaz
Budapest
Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
Budapest
Medical Oncology University Debrecen
Debrecen
University of Pécs
Pécs
Italy
Azienda Ospedaliero Universitaria Sant'Orsola Malpighi
Bologna
Candiolo Cancer Institute - FPO, IRCCS
Candiolo
AOUC Azienda Ospedaliero - Universitaria Careggi
Firenze
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Milano
Istituto Europeo di Oncologia
Milano
Universita degli Studi di Palermo - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo
Campus Bio-Medico - Oncology Medica
Roma
Netherlands
Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam
Radboud University Medical Center
Nijmegen
Erasmus Medical Center
Rotterdam
Poland
Sanodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie, Oddzial Kliniczny Onkologii
Kraków
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z W-MCO
Olsztyn
Maria Skodowska Curie Memorial Cancer Centre and Institute of Oncology
Warszawa
Dolnoslaskie Centrum Onkologii we Wrocawiu
Wrocław
Republic of Korea
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Ajou University Hospital
Suwon-si
Singapore
National Cancer Centre Singapore
Singapore
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
Institut Català d'Oncologia - Hospital Duran i Reynals
Barcelona
Vall d'Hebron
Barcelona
Hospital La Paz
Madrid
Hospital Universitario Gregorio Marañón
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Hospital Virgen del Rocio
Sevilla
Fundacion Instituto Valenciano de Oncologia, Servicio de Oncologia
Valencia
Hospital Universitario Miguel Servet
Zaragoza
Sweden
Skanes University Hospital
Lund
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow
Guy's Hospital
London
The Royal Marsden Hospital
London
The Christie NHS Foundation Trust
Manchester
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Time Frame
Start Date: 2018-03-26
Completion Date: 2021-09-15
Participants
Target number of participants: 476
Treatments
Experimental: avapritinib
300 mg PO QD
Active_comparator: regorafenib
160 mg PO QD
Authors
Margaret von Mehren, Sharad K Jain, Mihaela Druta, Victor Villalobos, David A. Liebner, Melissa Burgess, Mahesh Seetharam, Scott M. Schuetze, Johanna C. Bendell, Andrew D. McCollum, Jennifer Choe, John Charlson, David J Andorsky, Arvind Chaudhry, Jonathan Whisenant, Shreyaskumar Patel, Mark Agulnik, Rodolfo Bordoni, Lin Shen, Robin Jones, Brian Van Tine, Dennis A. Priebat, Thomas J. Harris, Scott H. Okuno, Arun S. Singh, Nicolas Penel, Emmanuelle Bompas, Sebastian Bauer, Peter Hohenberger, Francois Bertucci, Peter Reichardt, Daniel Pink, Mehdi Brahmi, Marit Ahrens, Stephan Richter, Antoine Italiano, William Tap, Michael Heinrich, Ricardo Cubedo, Yongjian Zhou, Thomas Brodowicz, Zsuzsanna Papai, Peter Arkosy, Xavier Garcia del Muro, Seok Y. Kang, Laszlo Mangel, Michael G. Leahy, Xin Wu, Yoon-Koo Kang, Thierry Gil, Paolo G. Casali, Patrick Schoffski, Stefan Sleijfer, Eva Segelov, Kuntang Shen, Gyorgy Bodoky, Ingrid Desar, Olivier Mir, Haijiang Wang, Desmond Yip, Petr Kavan, Zhichao Zheng, Albiruni Razak, Javier Martin Broto, Karen Mulder, Kaixiong Tao, Florence Duffaud, Mikael Eriksson, Zhigang Jie, Massimo Aglietta, Yanbing Zhou, Amitesh C. Roy, Piotr Rutkowski, Nagavalli Somasundaram, Tommaso M. De Pas, Neeltje Steeghs, Bohuslav Melichar, Giuseppe Badalamenti, Bruno Vincenzi, Cesar Serrano, Silvia Gasperoni, Sun Young Rha, Maria Pantaleo, Yanqiao Zhang
Related Therapeutic Areas
Sponsors
Leads: Blueprint Medicines Corporation