search
Back to results

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

Primary Purpose

GIST

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
avapritinib
regorafenib
Sponsored by
Blueprint Medicines Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GIST focused on measuring Other Relapsed or Refractory Solid Tumors, BLU-285, BLU 285, BLUE-285, BLUE 285, Avapritinib, GIST imatinib relapse, GIST gleevec relapse, GIST KIT, GIST relapse, GIST refractory, GIST imatinib intolerance, GIST TKI treatment, GIST tyrosine kinase inhibitor treatment, GIST TKI, GIST tyrosine kinase inhibitor, Advanced GIST, GIST mutations, GIST treatments, Blueprint GIST, Relapsed GIST clinical trial, Refractory GIST clinical trial, KIT-mutant GIST, cancer gist, gastrointestinal stromal tumor, gist cancer, PDGFRA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who are ≥ 18 years of age.
  2. Patients who have histologically confirmed metastatic or unresectable GIST.
  3. 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.
  4. Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.

Exclusion Criteria:

  1. Patients who have received prior treatment with avapritinib or regorafenib.
  2. Patients who have previously received more than 3 different TKI treatment regimens.
  3. Patients who are known to be both V-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT) and platelet-derived growth factor receptor alpha (PDGRFα) wild type.
  4. Patients who received any systemic anticancer therapy within 1 week before the first dose of study drug.
  5. Patients who have clinically significant cardiovascular disease
  6. Patients have experienced arterial thrombotic or embolic events within 6 months before the first dose of study drug, or venous thrombotic events within 14 days of the first dose of study drug
  7. Patients who have experienced any hemorrhage or bleeding event NCI CTCAE version 5.0 Grade 3 or higher within 4 weeks before the first dose of study drug
  8. Patients who have a known risk of intracranial bleeding, or a history of intracranial bleeding within 1 year prior to the first dose of study drug
  9. Patients who have a symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture.
  10. Patients who have poor organ function as defined by laboratory parameters specified in the protocol.
  11. Patients who have received neutrophil growth factor support within 14 days of first dose of study drug.
  12. Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4.
  13. Patients who have had a major surgical procedure within 14 days of the first dose of study drug. Patient has significant traumatic injury within 28 days before the first dose of study drug.
  14. Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 3 years before first dose of study drug.
  15. Patients who have a history of a seizure disorder requiring anti-seizure medication.
  16. Patients who have metastases to the brain.
  17. Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec.
  18. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of the first dose of study drug and for at least 60 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of the first dose of study drug and for at least 90 days after the last dose of study drug.
  19. Women who are pregnant.
  20. Women who are breastfeeding.
  21. Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality as determined by the investigator.

Sites / Locations

  • Mayo Clinic Cancer Center
  • UCLA Hematology/Oncology - Santa Monica
  • University of Colorado Hospital
  • Rocky Mountain Cancer Centers
  • Washington Hospital Center - Oncology and Hematology
  • Mayo Clinic Cancer Center
  • University of Miami
  • Moffitt Cancer Center
  • Northside Hospital
  • Northwestern Medicine
  • The University of Chicago Medical Center
  • Dana Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center
  • Mayo Clinic Cancer Center
  • Washington University in Saint Louis
  • Memorial Sloan Kettering Cancer Center
  • Duke University Medical Center
  • Ohio State University
  • OHSU - Knight Cancer Institute
  • Fox Chase Cancer Center
  • UPMC Hillman Cancer Center
  • Tennessee Oncology
  • USO - Texas Oncology
  • Texas Oncology - Denton South
  • University of Texas MD Anderson
  • Texas Oncology - Waco
  • Huntsman Cancer Institute
  • Fred Hutchinson Cancer Research Center
  • Summit Cancer Centers
  • Medical College of Wisconsin - Froedtert Hospital
  • Flinders Medical Center
  • Monash Health
  • The Canberra Hospital
  • AKH, Klinik f. Innere Med. I, Onkologie
  • Institut Jules Bordet
  • Leuven Cancer Institute
  • Cross Cancer Institute
  • University Health Network
  • Jewish General Hospital
  • Beijing Cancer Hospital
  • Chinese PLA General Hospital
  • West China Hospital Sichuan University
  • The First Affiliated Hospital of Chongqing Medical University
  • Fujian Medical University Union Hospital
  • The First Affiliated Hospital of Sun Yat-sen University
  • The Sixth Affiliated Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital, Zhejiang University
  • Harbin Medical University Cancer Hospital
  • The First Affiliated Hospital of Nanchang Medical University
  • Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
  • The Affiliated Hospital of Qingdao University
  • Fudan University Shanghai Cancer Center
  • Fudan University Zhongshan Hospital
  • Shanghai Jiaotong University School of Medicine, Renji Hospital
  • Liaoning Cancer Hospital & Institute
  • Tianjin Cancer Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Affiliated Cancer Hospital of Xinjiang Medical University
  • Onkologická klinika Fakultní nemocnice Olomouc
  • Fackultni Nemocnice v Motole
  • Institut Bergonié
  • Centre Oscar Lambret
  • UNICANCER - Lyon, Centre Léon-Bérard
  • Institute Paoli Calmettes
  • La Timone University Hospital
  • Institut Curie
  • Centre Rene Gauducheau
  • Gustave Roussy Cancer Campus
  • HELIOS Klinikum Bad Saarow
  • HELIOS Klinikum Berlin-Buch
  • Medizinische Fakultät Carl Gustav Carus
  • Universitaetsklindum Essen
  • Universitätsklinikum Frankfurt
  • Studienzentrale GbR Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt
  • Rupercht-Karls-Universitaet Heidelberg
  • Fovarosi Onkormanyzat Szent Laszlo Korhaz
  • Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
  • Medical Oncology University Debrecen
  • University of Pécs
  • Azienda Ospedaliero Universitaria Sant'Orsola Malpighi
  • Candiolo Cancer Institute - FPO, IRCCS
  • AOUC Azienda Ospedaliero - Universitaria Careggi
  • Fondazione IRCCS Istituto Nazionale dei Tumori Milano
  • Istituto Europeo di Oncologia
  • Universita degli Studi di Palermo - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Campus Bio-Medico - Oncology Medica
  • Ajou University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital
  • Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis
  • Radboud University Medical Center
  • Erasmus Medical Center
  • Sanodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie, Oddzial Kliniczny Onkologii
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z W-MCO
  • Maria Skodowska Curie Memorial Cancer Centre and Institute of Oncology
  • Dolnoslaskie Centrum Onkologii we Wrocawiu
  • National Cancer Centre Singapore
  • Hospital de la Santa Creu i Sant Pau
  • Institut Català d'Oncologia - Hospital Duran i Reynals
  • Vall d'Hebron
  • Hospital La Paz
  • Hospital Universitario Gregorio Marañón
  • Hospital Universitario Puerta de Hierro
  • Hospital Virgen del Rocio
  • Fundacion Instituto Valenciano de Oncologia, Servicio de Oncologia
  • Hospital Universitario Miguel Servet
  • Skanes University Hospital
  • Beatson West of Scotland Cancer Centre
  • The Royal Marsden Hospital
  • Guy's Hospital
  • The Christie NHS Foundation Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

avapritinib

regorafenib

Arm Description

300 mg PO QD

160 mg PO QD

Outcomes

Primary Outcome Measures

Efficacy of Avapritinib Based on Progression-free Survival (PFS) Determined by Central Radiological Assessment Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST), Version 1.1
To demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST following 2 or 3 regimens of prior treatment with a tyrosine kinase inhibitor (TKI), including imatinib, compared to patients treated with regorafenib. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies.

Secondary Outcome Measures

Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1
To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib. A complete response (CR) per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response (PR) is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR
Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
The Global Health Status Score is derived from question 29 and 30 on the EORTC-QLQ-C30 tool. The change in score was assessed between baseline and week 12 in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib. The Global Health Status Score score range is 0 to 100 with a higher score indicating better global health status. A positive change indicates improvement in global health status.

Full Information

First Posted
March 7, 2018
Last Updated
September 9, 2022
Sponsor
Blueprint Medicines Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03465722
Brief Title
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blueprint Medicines Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GIST
Keywords
Other Relapsed or Refractory Solid Tumors, BLU-285, BLU 285, BLUE-285, BLUE 285, Avapritinib, GIST imatinib relapse, GIST gleevec relapse, GIST KIT, GIST relapse, GIST refractory, GIST imatinib intolerance, GIST TKI treatment, GIST tyrosine kinase inhibitor treatment, GIST TKI, GIST tyrosine kinase inhibitor, Advanced GIST, GIST mutations, GIST treatments, Blueprint GIST, Relapsed GIST clinical trial, Refractory GIST clinical trial, KIT-mutant GIST, cancer gist, gastrointestinal stromal tumor, gist cancer, PDGFRA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
476 (Actual)

8. Arms, Groups, and Interventions

Arm Title
avapritinib
Arm Type
Experimental
Arm Description
300 mg PO QD
Arm Title
regorafenib
Arm Type
Active Comparator
Arm Description
160 mg PO QD
Intervention Type
Drug
Intervention Name(s)
avapritinib
Other Intervention Name(s)
BLU-285
Intervention Description
Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
Intervention Type
Drug
Intervention Name(s)
regorafenib
Other Intervention Name(s)
Stivarga
Intervention Description
Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
Primary Outcome Measure Information:
Title
Efficacy of Avapritinib Based on Progression-free Survival (PFS) Determined by Central Radiological Assessment Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST), Version 1.1
Description
To demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST following 2 or 3 regimens of prior treatment with a tyrosine kinase inhibitor (TKI), including imatinib, compared to patients treated with regorafenib. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1
Description
To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib. A complete response (CR) per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response (PR) is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR
Time Frame
24 Months
Title
Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
Description
To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib
Time Frame
24 Months
Title
European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
Description
The Global Health Status Score is derived from question 29 and 30 on the EORTC-QLQ-C30 tool. The change in score was assessed between baseline and week 12 in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib. The Global Health Status Score score range is 0 to 100 with a higher score indicating better global health status. A positive change indicates improvement in global health status.
Time Frame
Difference between baseline and week 12 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients who have received prior treatment with avapritinib or regorafenib. Patients who have previously received more than 3 different TKI treatment regimens. Patients who are known to be both V-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT) and platelet-derived growth factor receptor alpha (PDGRFα) wild type. Patients who received any systemic anticancer therapy within 1 week before the first dose of study drug. Patients who have clinically significant cardiovascular disease Patients have experienced arterial thrombotic or embolic events within 6 months before the first dose of study drug, or venous thrombotic events within 14 days of the first dose of study drug Patients who have experienced any hemorrhage or bleeding event NCI CTCAE version 5.0 Grade 3 or higher within 4 weeks before the first dose of study drug Patients who have a known risk of intracranial bleeding, or a history of intracranial bleeding within 1 year prior to the first dose of study drug Patients who have a symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture. Patients who have poor organ function as defined by laboratory parameters specified in the protocol. Patients who have received neutrophil growth factor support within 14 days of first dose of study drug. Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4. Patients who have had a major surgical procedure within 14 days of the first dose of study drug. Patient has significant traumatic injury within 28 days before the first dose of study drug. Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 3 years before first dose of study drug. Patients who have a history of a seizure disorder requiring anti-seizure medication. Patients who have metastases to the brain. Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of the first dose of study drug and for at least 60 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of the first dose of study drug and for at least 90 days after the last dose of study drug. Women who are pregnant. Women who are breastfeeding. Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality as determined by the investigator.
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Washington Hospital Center - Oncology and Hematology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University in Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OHSU - Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
USO - Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
University of Texas MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Summit Cancer Centers
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Medical College of Wisconsin - Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Flinders Medical Center
City
Adelaide
Country
Australia
Facility Name
Monash Health
City
Clayton
Country
Australia
Facility Name
The Canberra Hospital
City
Garran
Country
Australia
Facility Name
AKH, Klinik f. Innere Med. I, Onkologie
City
Wien
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
Country
Belgium
Facility Name
Leuven Cancer Institute
City
Leuven
Country
Belgium
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
Country
Canada
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
Country
China
Facility Name
The First Affiliated Hospital of Nanchang Medical University
City
Nanchang
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
City
Nanning
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Jiaotong University School of Medicine, Renji Hospital
City
Shanghai
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Affiliated Cancer Hospital of Xinjiang Medical University
City
Ürümqi
Country
China
Facility Name
Onkologická klinika Fakultní nemocnice Olomouc
City
Olomouc
Country
Czechia
Facility Name
Fackultni Nemocnice v Motole
City
Praha
Country
Czechia
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
UNICANCER - Lyon, Centre Léon-Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institute Paoli Calmettes
City
Marseille
Country
France
Facility Name
La Timone University Hospital
City
Marseille
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
Centre Rene Gauducheau
City
Saint-Herblain
Country
France
Facility Name
Gustave Roussy Cancer Campus
City
Villejuif
Country
France
Facility Name
HELIOS Klinikum Bad Saarow
City
Bad Saarow
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
Country
Germany
Facility Name
Medizinische Fakultät Carl Gustav Carus
City
Dresden
Country
Germany
Facility Name
Universitaetsklindum Essen
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Studienzentrale GbR Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt
City
Lubeck
Country
Germany
Facility Name
Rupercht-Karls-Universitaet Heidelberg
City
Mannheim
Country
Germany
Facility Name
Fovarosi Onkormanyzat Szent Laszlo Korhaz
City
Budapest
Country
Hungary
Facility Name
Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
City
Budapest
Country
Hungary
Facility Name
Medical Oncology University Debrecen
City
Debrecen
Country
Hungary
Facility Name
University of Pécs
City
Pécs
Country
Hungary
Facility Name
Azienda Ospedaliero Universitaria Sant'Orsola Malpighi
City
Bologna
Country
Italy
Facility Name
Candiolo Cancer Institute - FPO, IRCCS
City
Candiolo
Country
Italy
Facility Name
AOUC Azienda Ospedaliero - Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
City
Milano
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
Country
Italy
Facility Name
Universita degli Studi di Palermo - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
Country
Italy
Facility Name
Campus Bio-Medico - Oncology Medica
City
Roma
Country
Italy
Facility Name
Ajou University Hospital
City
Suwon-si
State/Province
Gyeong Gi-do
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis
City
Amsterdam
Country
Netherlands
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Sanodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie, Oddzial Kliniczny Onkologii
City
Kraków
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z W-MCO
City
Olsztyn
Country
Poland
Facility Name
Maria Skodowska Curie Memorial Cancer Centre and Institute of Oncology
City
Warszawa
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii we Wrocawiu
City
Wrocław
Country
Poland
Facility Name
National Cancer Centre Singapore
City
Singapore
Country
Singapore
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Institut Català d'Oncologia - Hospital Duran i Reynals
City
Barcelona
Country
Spain
Facility Name
Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Fundacion Instituto Valenciano de Oncologia, Servicio de Oncologia
City
Valencia
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
Skanes University Hospital
City
Lund
Country
Sweden
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34343033
Citation
Kang YK, George S, Jones RL, Rutkowski P, Shen L, Mir O, Patel S, Zhou Y, von Mehren M, Hohenberger P, Villalobos V, Brahmi M, Tap WD, Trent J, Pantaleo MA, Schoffski P, He K, Hew P, Newberry K, Roche M, Heinrich MC, Bauer S. Avapritinib Versus Regorafenib in Locally Advanced Unresectable or Metastatic GI Stromal Tumor: A Randomized, Open-Label Phase III Study. J Clin Oncol. 2021 Oct 1;39(28):3128-3139. doi: 10.1200/JCO.21.00217. Epub 2021 Aug 3.
Results Reference
derived
PubMed Identifier
30274985
Citation
Gebreyohannes YK, Wozniak A, Zhai ME, Wellens J, Cornillie J, Vanleeuw U, Evans E, Gardino AK, Lengauer C, Debiec-Rychter M, Sciot R, Schoffski P. Robust Activity of Avapritinib, Potent and Highly Selective Inhibitor of Mutated KIT, in Patient-derived Xenograft Models of Gastrointestinal Stromal Tumors. Clin Cancer Res. 2019 Jan 15;25(2):609-618. doi: 10.1158/1078-0432.CCR-18-1858. Epub 2018 Oct 1.
Results Reference
derived

Learn more about this trial

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

We'll reach out to this number within 24 hrs