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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465722
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Blueprint Medicines Corporation

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.

Condition or disease Intervention/treatment Phase
GIST Drug: avapritinib Drug: regorafenib Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2023


Arm Intervention/treatment
Experimental: avapritinib
300 mg PO QD
Drug: avapritinib
Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
Other Name: BLU-285

Active Comparator: regorafinib
160 mg PO QD
Drug: regorafenib
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).
Other Name: Stivarga




Primary Outcome Measures :
  1. 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 [ Time Frame: 24 Months ]
    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


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 [ Time Frame: 24 Months ]
    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

  2. Overall Survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib [ Time Frame: 60 Months ]
    To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib

  3. European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30) individual scores in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib [ Time Frame: 12 Weeks ]
    To evaluate mean change from baseline to week 12 in the EORTC-QLQ-30 individual scores in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465722


Locations
Hide Hide 114 study locations
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United States, Arizona
Mayo Clinic Cancer Center
Phoenix, Arizona, United States, 85054
United States, California
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Boulder, Colorado, United States, 80303
United States, District of Columbia
Washington Hospital Center - Oncology and Hematology
Washington, District of Columbia, United States, 20010
United States, Florida
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
University of Miami
Miami, Florida, United States, 33146
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30341
United States, Illinois
Northwestern Medicine
Chicago, Illinois, United States, 60611
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University in Saint Louis
Saint Louis, Missouri, United States, 63130
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
OHSU - Knight Cancer Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
USO - Texas Oncology
Dallas, Texas, United States, 75246
Texas Oncology - Denton South
Denton, Texas, United States, 76210
University of Texas MD Anderson
Houston, Texas, United States, 77030
Texas Oncology - Waco
Waco, Texas, United States, 76712
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Summit Cancer Centers
Spokane, Washington, United States, 99216
United States, Wisconsin
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Australia
Flinders Medical Center
Adelaide, Australia
Monash Health
Clayton, Australia
The Canberra Hospital
Garran, Australia
Austria
AKH, Klinik f. Innere Med. I, Onkologie
Wien, Austria
Belgium
Institut Jules Bordet
Brussels, Belgium
Leuven Cancer Institute
Leuven, Belgium
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 1L7
Canada
Jewish General Hospital
Montréal, Canada
China
Beijing Cancer Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
West China Hospital Sichuan University
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
The First Affiliated Hospital of Nanchang Medical University
Nanchang, China
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
Nanning, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Fudan University Shanghai Cancer Center
Shanghai, China
Fudan University Zhongshan Hospital
Shanghai, China
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, China
Liaoning Cancer Hospital & Institute
Shenyang, China
Tianjin Cancer Hospital
Tianjin, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China
Czechia
Onkologická klinika Fakultní nemocnice Olomouc
Olomouc, Czechia
Fackultni Nemocnice v Motole
Praha, Czechia
France
Institut Bergonié
Bordeaux, France
Centre Oscar Lambret
Lille, France
UNICANCER - Lyon, Centre Léon-Bérard
Lyon, France, 69008
Institute Paoli Calmettes
Marseille, France
La Timone University Hospital
Marseille, France
Institut Curie
Paris, France
Centre Rene Gauducheau
Saint-Herblain, France
Gustave Roussy Cancer Campus
Villejuif, France
Germany
HELIOS Klinikum Bad Saarow
Bad Saarow, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Medizinische Fakultät Carl Gustav Carus
Dresden, Germany
Universitaetsklindum Essen
Essen, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Studienzentrale GbR Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt
Lubeck, Germany
Rupercht-Karls-Universitaet Heidelberg
Mannheim, Germany
Hungary
Fovarosi Onkormanyzat Szent Laszlo Korhaz
Budapest, Hungary
Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
Budapest, Hungary
Medical Oncology University Debrecen
Debrecen, Hungary
University of Pécs
Pécs, Hungary
Italy
Azienda Ospedaliero Universitaria Sant'Orsola Malpighi
Bologna, Italy
Candiolo Cancer Institute - FPO, IRCCS
Candiolo, Italy
AOUC Azienda Ospedaliero - Universitaria Careggi
Firenze, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Milano, Italy
Istituto Europeo di Oncologia
Milano, Italy
Universita degli Studi di Palermo - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Campus Bio-Medico - Oncology Medica
Roma, Italy
Korea, Republic of
Ajou University Hospital
Suwon-si, Gyeong Gi-do, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Netherlands
Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Poland
Sanodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie, Oddzial Kliniczny Onkologii
Kraków, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z W-MCO
Olsztyn, Poland
Maria Skodowska Curie Memorial Cancer Centre and Institute of Oncology
Warszawa, Poland
Dolnoslaskie Centrum Onkologii we Wrocawiu
Wrocław, Poland
Singapore
National Cancer Centre Singapore
Singapore, Singapore
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals
Barcelona, Spain
Vall d'Hebron
Barcelona, Spain
Hospital La Paz
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Virgen del Rocio
Sevilla, Spain
Fundacion Instituto Valenciano de Oncologia, Servicio de Oncologia
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Sweden
Skanes University Hospital
Lund, Sweden
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
The Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Guy's Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Sponsors and Collaborators
Blueprint Medicines Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Blueprint Medicines Corporation
ClinicalTrials.gov Identifier: NCT03465722    
Other Study ID Numbers: BLU-285-1303
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blueprint Medicines Corporation:
Other Relapsed or Refractory Solid Tumors
cancer gist
gastrointestinal stromal tumor
gist cancer
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
PDGFRA
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases