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

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ClinicalTrials.gov Identifier: NCT03465722
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : September 25, 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)
Estimated Enrollment : 460 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


Contacts
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Contact: Blueprint Medicines 617-714-6707 studydirector@blueprintmedicines.com

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Locations
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United States, Arizona
Mayo Clinic Cancer Center Recruiting
Phoenix, Arizona, United States, 85054
Principal Investigator: Mahesh Seetharam         
United States, California
UCLA Hematology/Oncology - Santa Monica Recruiting
Santa Monica, California, United States, 90404
Principal Investigator: Arun S. Singh         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Victor Villalobos         
Rocky Mountain Cancer Centers Recruiting
Boulder, Colorado, United States, 80303
Principal Investigator: David J Andorsky         
United States, District of Columbia
Washington Hospital Center - Oncology and Hematology Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Dennis A. Priebat         
United States, Florida
Mayo Clinic Cancer Center Recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Steven Attia         
University of Miami Recruiting
Miami, Florida, United States, 33146
Principal Investigator: Jonathan C. Trent         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Mihaela Druta         
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30341
Principal Investigator: Rodolfo Bordoni         
United States, Illinois
Northwestern Medicine Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Mark Agulnik         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Suzanne George         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Scott M. Schuetze         
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Scott H. Okuno         
United States, Missouri
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63130
Principal Investigator: Brian Van Tine         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Principal Investigator: William Tap         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Jennifer Choe         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: David A. Liebner         
United States, Oregon
OHSU - Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Michael Heinrich         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Margaret von Mehren         
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Melissa Burgess         
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Johanna C. Bendell         
United States, Texas
USO - Texas Oncology Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Andrew D. McCollum         
Texas Oncology - Denton South Recruiting
Denton, Texas, United States, 76210
Principal Investigator: Sharad K Jain         
University of Texas MD Anderson Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Shreyaskumar Patel         
Texas Oncology - Waco Recruiting
Waco, Texas, United States, 76712
Principal Investigator: Thomas J. Harris         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: Jonathan Whisenant         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Lee Cranmer         
Summit Cancer Centers Recruiting
Spokane, Washington, United States, 99216
Principal Investigator: Arvind Chaudhry         
United States, Wisconsin
Medical College of Wisconsin - Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: John Charlson         
Australia
Flinders Medical Center Recruiting
Adelaide, Australia
Principal Investigator: Amitesh C. Roy         
Monash Health Recruiting
Clayton, Australia
Principal Investigator: Eva Segelov         
The Canberra Hospital Recruiting
Garran, Australia
Principal Investigator: Desmond Yip         
Austria
AKH, Klinik f. Innere Med. I, Onkologie Recruiting
Wien, Austria
Principal Investigator: Thomas Brodowicz         
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium
Principal Investigator: Thierry Gil         
Leuven Cancer Institute Recruiting
Leuven, Belgium
Principal Investigator: Patrick Schoffski         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Karen Mulder         
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 1L7
Principal Investigator: Albiruni Razak         
Canada
Jewish General Hospital Recruiting
Montréal, Canada
Principal Investigator: Petr Kavan         
China
Beijing Cancer Hospital Recruiting
Beijing, China
Principal Investigator: Lin Shen         
Chinese PLA General Hospital Recruiting
Beijing, China
Principal Investigator: Xin Wu         
West China Hospital Sichuan University Recruiting
Chengdu, China
Principal Investigator: Bo Zhang         
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, China
Principal Investigator: Jun Zhang         
Fujian Medical University Union Hospital Recruiting
Fuzhou, China
Principal Investigator: Yongjian Zhou         
The Sixth Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, China
Principal Investigator: Yanhong Deng         
Harbin Medical University Cancer Hospital Recruiting
Harbin, China
Principal Investigator: Yanqiao Zhang         
The First Affiliated Hospital of Nanchang Medical University Recruiting
Nanchang, China
Principal Investigator: Zhigang Jie         
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College Recruiting
Nanning, China
Principal Investigator: Jianxi Chen         
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, China
Principal Investigator: Yanbing Zhou         
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Principal Investigator: Ye Zhou         
Fudan University Zhongshan Hospital Recruiting
Shanghai, China
Principal Investigator: Kuntang Shen         
Shanghai Jiaotong University School of Medicine, Renji Hospital Recruiting
Shanghai, China
Principal Investigator: Hui Cao         
Liaoning Cancer Hospital & Institute Recruiting
Shenyang, China
Principal Investigator: Zhichao Zheng         
Tianjin Cancer Hospital Recruiting
Tianjin, China
Principal Investigator: Liang Han         
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, China
Principal Investigator: Kaixiong Tao         
Affiliated Cancer Hospital of Xinjiang Medical University Recruiting
Ürümqi, China
Principal Investigator: Haijiang Wang         
Czechia
Onkologická klinika Fakultní nemocnice Olomouc Recruiting
Olomouc, Czechia
Principal Investigator: Bohuslav Melichar         
Fackultni Nemocnice v Motole Recruiting
Praha, Czechia
Principal Investigator: Jana Prausova         
France
Institut Bergonié Recruiting
Bordeaux, France
Principal Investigator: Antoine Italiano         
Centre Oscar Lambret Recruiting
Lille, France
Principal Investigator: Nicolas Penel         
UNICANCER - Lyon, Centre Léon-Bérard Recruiting
Lyon, France, 69008
Principal Investigator: Mehdi Brahmi         
Institute Paoli Calmettes Recruiting
Marseille, France
Principal Investigator: Francois Bertucci         
La Timone University Hospital Recruiting
Marseille, France
Principal Investigator: Florence Duffaud         
Centre Rene Gauducheau Recruiting
Saint-Herblain, France
Principal Investigator: Emmanuelle Bompas         
Gustave Roussy Cancer Campus Recruiting
Villejuif, France
Principal Investigator: Olivier Mir         
Germany
HELIOS Klinikum Bad Saarow Recruiting
Bad Saarow, Germany
Principal Investigator: Daniel Pink         
HELIOS Klinikum Berlin-Buch Recruiting
Berlin, Germany
Principal Investigator: Peter Reichardt         
Medizinische Fakultät Carl Gustav Carus Recruiting
Dresden, Germany
Principal Investigator: Stephan Richter         
Universitaetsklindum Essen Recruiting
Essen, Germany
Principal Investigator: Sebastian Bauer         
Universitätsklinikum Frankfurt Recruiting
Frankfurt, Germany
Principal Investigator: Marit Ahrens         
Studienzentrale GbR Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt Recruiting
Lubeck, Germany
Principal Investigator: Jens Kisro         
Rupercht-Karls-Universitaet Heidelberg Recruiting
Mannheim, Germany
Principal Investigator: Peter Hohenberger         
Hungary
Fovarosi Onkormanyzat Szent Laszlo Korhaz Recruiting
Budapest, Hungary
Principal Investigator: Gyorgy Bodoky         
Magyar Honvédség Egészségügyi Központ Onkológiai Osztály Recruiting
Budapest, Hungary
Principal Investigator: Zsuzsanna Papai         
Medical Oncology University Debrecen Recruiting
Debrecen, Hungary
Principal Investigator: Peter Arkosy         
University of Pécs Recruiting
Pécs, Hungary
Principal Investigator: Laszlo Mangel         
Italy
Azienda Ospedaliero Universitaria Sant'Orsola Malpighi Recruiting
Bologna, Italy
Principal Investigator: Maria Pantaleo         
Candiolo Cancer Institute - FPO, IRCCS Recruiting
Candiolo, Italy
Principal Investigator: Massimo Aglietta         
AOUC Azienda Ospedaliero - Universitaria Careggi Recruiting
Firenze, Italy
Principal Investigator: Silvia Gasperoni         
Fondazione IRCCS Istituto Nazionale dei Tumori Milano Recruiting
Milano, Italy
Principal Investigator: Paolo G. Casali         
Istituto Europeo di Oncologia Recruiting
Milano, Italy
Principal Investigator: Tommaso M. De Pas         
Universita degli Studi di Palermo - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Recruiting
Palermo, Italy
Principal Investigator: Giuseppe Badalamenti         
Campus Bio-Medico - Oncology Medica Recruiting
Roma, Italy
Principal Investigator: Bruno Vincenzi         
Korea, Republic of
Ajou University Hospital Recruiting
Suwon-si, Gyeong Gi-do, Korea, Republic of
Principal Investigator: Seok Y. Kang         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Yoon-Koo Kang         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Joon O. Park         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Kyung-Hun Lee         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Sun Young Rha         
Netherlands
Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis Recruiting
Amsterdam, Netherlands
Principal Investigator: Neeltje Steeghs         
Radboud University Medical Center Recruiting
Nijmegen, Netherlands
Principal Investigator: Ingrid Desar         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Principal Investigator: Stefan Sleijfer         
Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z W-MCO Recruiting
Olsztyn, Poland
Principal Investigator: Pawel Rozanowski         
Maria Skodowska Curie Memorial Cancer Centre and Institute of Oncology Recruiting
Warszawa, Poland
Principal Investigator: Piotr Rutkowski         
Dolnoslaskie Centrum Onkologii we Wrocawiu Recruiting
Wrocław, Poland
Principal Investigator: Piotr Hudziec         
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore
Principal Investigator: Nagavalli Somasundaram         
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Principal Investigator: Ana Sebio Garcia         
Institut Català d'Oncologia - Hospital Duran i Reynals Recruiting
Barcelona, Spain
Principal Investigator: Xavier Garcia del Muro         
Vall d'Hebron Recruiting
Barcelona, Spain
Principal Investigator: Cesar Serrano         
Hospital La Paz Recruiting
Madrid, Spain
Principal Investigator: Virginia Martinez Marin         
Hospital Universitario Gregorio Marañón Recruiting
Madrid, Spain
Principal Investigator: Antonio Calles Blanco         
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain
Principal Investigator: Ricardo Cubedo         
Hospital Virgen del Rocio Recruiting
Sevilla, Spain
Principal Investigator: Javier Martin Broto         
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain
Principal Investigator: Javier Martinez Trufero         
Sweden
Skanes University Hospital Recruiting
Lund, Sweden
Principal Investigator: Mikael Eriksson         
United Kingdom
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom
Principal Investigator: Jeffrey D. White         
The Royal Marsden Hospital Recruiting
London, United Kingdom, SW3 6JJ
Principal Investigator: Robin Jones         
Guy's Hospital Recruiting
London, United Kingdom
Principal Investigator: Sarah Ngan         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Principal Investigator: Michael G. Leahy         
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, United Kingdom
Principal Investigator: Robin J. Young         
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     History of Changes
Other Study ID Numbers: BLU-285-1303
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 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