Clinical trial NCT05253651: A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
Official title: An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colorectal Neoplasms
Keywords: Colorectal Cancer
CRC
Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).

Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:

* mFOLFOX6 alone,
* mFOLFOX6 with bevacizumab, or
* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
* Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory

  * If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
* HER2+ disease as determined by a tissue based assay performed at a central laboratory.
* Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
* Radiographically measurable disease per RECIST v1.1 with:

  * At least one site of disease that is measurable and that has not been previously irradiated, or
  * If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:

  * No evidence of brain metastases
  * Previously treated brain metastases which are asymptomatic

Exclusion Criteria:

* Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.

  * Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \>6 months prior to enrollment
* Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
* Previous treatment with anti-HER2 therapy
* Ongoing Grade 3 or higher neuropathy
* Active or untreated gastrointestinal (GI) perforation at the time of screening.

Primary outcomes:
measure: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 6 years
measure: Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
timeFrame: Up to approximately 3 years
measure: PFS per RECIST v1.1 by investigator assessment
timeFrame: Up to approximately 3 years
measure: cORR per RECIST v1.1 by investigator assessment
timeFrame: Up to approximately 3 years
measure: Duration of response (DOR) per RECIST v1.1 by BICR
timeFrame: Up to approximately 3 years
measure: DOR per RECIST v1.1 by investigator assessment
timeFrame: Up to approximately 3 years
measure: Time to second progression or death (PFS2)
timeFrame: Up to approximately 3 years
measure: Incidence of adverse events (AEs)
timeFrame: Through 30 days after the last study treatment; approximately 1 year
measure: Incidence of dose alterations
timeFrame: Through 30 days after the last study treatment; approximately 1 year
measure: Trough concentration (Ctrough)
timeFrame: Approximately 4 months
measure: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
timeFrame: Through 30-37 days after the last study treatment; approximately 1 year
measure: Time to meaningful change in EORTC QLQ30 score
timeFrame: Through 30-37 days after the last study treatment; approximately 1 year
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Building - Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center Inc.
state: California
city: Anaheim
country: United States
facility: Kaiser Permanente Anaheim Kraemer Medical Offices
state: California
city: Baldwin Park
country: United States
facility: Kaiser Permanente Baldwin Park Medical Center
state: California
city: Bellflower
country: United States
facility: Kaiser Permanente Bellflower Medical Offices
state: California
city: Fontana
country: United States
facility: Kaiser Permanente Fontana Medical Center
state: California
city: Glendale
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Glendale
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Harbor City
country: United States
facility: Kaiser Permanente South Bay Medical center
state: California
city: Irvine
country: United States
facility: Kaiser Permanente Alton/Sand Canyon Medical Offices
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: USC Norris Koreatown - Medical Oncology
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Offices
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente West Los Angeles Medical Center
state: California
city: Newport Beach
country: United States
facility: USC Norris Oncology/Hematology - Newport Beach
state: California
city: Ontario
country: United States
facility: Kaiser Permanente Ontario Medical Center
state: California
city: Panorama City
country: United States
facility: Kaiser Permanente Panorama City Medical Center
state: California
city: Pasadena
country: United States
facility: Keck Medical Center of USC Pasadena
state: California
city: Pasadena
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Zion Medical Center
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente San Marcos Medical Offices
state: California
city: Van Nuys
country: United States
facility: Los Angeles Hematology Oncology Medical Group
state: California
city: Woodland Hills
country: United States
facility: Kaiser Permanente Woodland Hills Medical Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Pueblo
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Aventura
country: United States
facility: Mount Sinai Medical Center Aventura ER
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Grady Memorial Hospital Investigational Drug Service
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Investigational Drug Service
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Merriam
country: United States
facility: Alliance for Multispecialty Research LLC.
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute - Downtown
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Downtown
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Audubon Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Audubon Hospital Campus
state: Kentucky
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Brownsboro Hospital Campus
state: Kentucky
city: Burnsville
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Coon Rapids
country: United States
facility: Allina Health Cancer institute
state: Minnesota
city: Coon Rapids
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Edina
country: United States
facility: M Health Fairview Cancer Clinic-Edina
state: Minnesota
city: Edina
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Fridley
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Maple Grove
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Maplewood
country: United States
facility: M Health Fairview St. John's Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute (Virginia Piper Cancer Institute)
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Health Cancer Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center Outpatient Pharmacy
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Regulatory Location: MMCORC
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Oncology Hematology, PA St. Paul Cancer Center
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology, PA Cornerstone Medical Specialty Center
state: Minnesota
city: Basking Ridge
country: United States
facility: MSK Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: MSK Monmouth
state: New Jersey
city: Montvale
country: United States
facility: MSK Bergen
state: New Jersey
city: Commack
country: United States
facility: MSK Commack
state: New York
city: Harrison
country: United States
facility: MSK Westchester
state: New York
city: New York
country: United States
facility: Rockefeller Outpatient Pavilion (53rd Street)
state: New York
city: New York
country: United States
facility: Memorial Solan Kettering Cancer Center- Main Campus
state: New York
city: Uniondale
country: United States
facility: MSK Nassau
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center, Duke Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Cancer Center
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Newberg
country: United States
facility: Providence Cancer Institute Newberg Clinic
state: Oregon
city: Oregon City
country: United States
facility: Providence Cancer Institute Willamette Falls Clinic
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Oncology and Hematology Care Clinic - Westside
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center- Investigational Drug Services
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Beaver
country: United States
facility: UPMC Hillman Cancer Center - Beaver
state: Pennsylvania
city: Butler
country: United States
facility: UPMC Hillman Cancer Center at Butler Health System
state: Pennsylvania
city: Erie
country: United States
facility: UPMC Hillman Cancer Center Erie
state: Pennsylvania
city: Greensburg
country: United States
facility: UPMC Hillman Cancer Center at Arnold Palmer Pavilion
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Hillman Cancer Center - Pinnacle (Community Osteopathic / Medical Sciences Pavillion)
state: Pennsylvania
city: Irwin
country: United States
facility: UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health
state: Pennsylvania
city: Irwin
country: United States
facility: UPMC Hillman Cancer Center at Arnold Palmer Pavilion
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: UPMC Hillman Cancer Center - Pinnacle (Ortenzio Cancer Center)
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Hillman Cancer Center - Monroeville
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - St Margarets
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - Passavant (HOA)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: St. Clair Cancer Center Medical Oncology
state: Pennsylvania
city: Washington
country: United States
facility: UPMC Hillman Cancer Center - Washington
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Product Center (IPC)
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center(IPC)
state: Texas
city: Blacksburg
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
state: Virginia
city: Low Moor
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia
state: Virginia
city: Roanoke
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
state: Virginia
city: Wytheville
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos
state: Santa FE
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Cordoba
country: Argentina
facility: IONC Instituto Oncologico de Cordoba Fundacion Richardet Longo
city: Cordoba
country: Argentina
facility: CEMAIC - Centro Medico Privado
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Townsville
country: Australia
facility: Townsville Hospital and Health Service
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH Austria
state: Upper Austria
city: Salzburg
country: Austria
facility: Landesapotheke Salzburg
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg, Landeskrankenhaus
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH Austria
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: UZA
city: Haine-Saint-Paul
country: Belgium
facility: CHU HELORA - Hopital de Jolimont
city: Liège
country: Belgium
facility: Centre Hospitalier Chretien - Clinique MontLegia
city: Turnhout
country: Belgium
facility: Maag-,Darm- en Leverziekten AZ Turnhout
city: Turnhout
country: Belgium
facility: Oncologisch Dagziekenhuis AZ Turnhout Campus Sint-Elisabeth
city: Curitiba
country: Brazil
facility: CIONC-Centro Integrado de Oncologia de Curitiba
state: Parana
city: Porto Alegre
country: Brazil
facility: Centro Integrado de Pesquisa em Oncologia CIPO-GHC / Hospital Nossa Senhora da Conceicao
state: RIO Grande DO SUL
city: Rio de Janeiro
country: Brazil
facility: Institute de Educacao, Pesquisa e Gestao em Saude - Instituto COI
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Institute de Educacao, Pesquisa e Gestao em Saude - Instituto COI
state: RJ
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos/Fundacao Pio XII
state: SAO Paulo
city: Jau
country: Brazil
facility: Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
state: SAO Paulo
city: Santo Andre
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia.
state: SAO Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: SP
city: Sao Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira.
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Viña del Mar
country: Chile
facility: Oncocentro Apys
state: Valparaíso
city: Concepcion
country: Chile
facility: Biocenter
city: Santiago
country: Chile
facility: Centro de estudios clinicos SAGA
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force
state: Fujian
city: Lanzhou
country: China
facility: The First hospital of LanZhou university
state: Gansu
city: Guangzhou
country: China
facility: The Sixth Affiliated hospital, Sun Yat-sen University
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital - Guangdong Province
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's hospital
state: Guangdong
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Chengde City
country: China
facility: Affiliated Hospital of Chengde Medical University
state: Hebei
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan People's Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Nanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Changzhou
country: China
facility: Changzhou Cancer Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chongqing
country: China
facility: Army Specialty Medical Center of The Chinese People's Liberation Army
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Besancon Cedex
country: France
facility: Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
state: Other
city: Avignon cedex 9
country: France
facility: Institut Sainte Catherine
city: Brest
country: France
facility: CHU Brest Hopital Cavale Blanche
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: Center Georges-Francois Leclerc
city: LYON Cedex 3
country: France
facility: Hopital Edouard Herriot
city: Marseille CEDEX 8
country: France
facility: Höpital Saint-Joseph
city: Nantes Cedex 1
country: France
facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Pharmacy Address:Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Saint-Antoine
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Pessac
country: France
facility: CHU Bordeaux Hopital Haut Leveque
city: Poitiers
country: France
facility: CHU Poitiers
city: ROUEN Cedex
country: France
facility: CHU de Rouen
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - Saint-Herblain
city: Saint Priest En Jarez
country: France
facility: Centre Hospitalier Universitaire Sainte-Etienne - Hopital Nord
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
city: Muenchen
country: Germany
facility: CCC Muenchen TUM
state: Bavaria
city: München
country: Germany
facility: LMU Klinikum - Campus Großhadern
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
state: Niedersachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Leipzig
country: Germany
facility: Landesdirektion Sachsen Dienststelle Leipzig
state: Saxony
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: Apotheke Johannstadt
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie - Onkologie
city: Dresden
country: Germany
facility: Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Frankfurt
country: Germany
facility: Agaplesion Frankfurter Diakonie Kliniken gGmbH
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Hamburg
country: Germany
facility: Hämatologisch Onkologische Praxis Eppendorf (HOPE)
city: Hamburg
country: Germany
facility: ZytoService Deutschland GmbH
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg GmbH
city: Hamburg
country: Germany
facility: Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TU München, Krankenhausapotheke
city: Munchen
country: Germany
facility: Klinikum Rechts der Isar der Technischen Universitaet Muenchen
city: Mönchengladbach
country: Germany
facility: Klinik für Hämatologie, Onkologie und Gastroenterologie
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen
city: Neuss
country: Germany
facility: Zentrale Apotheke - Rheinland Klinikum Lukaskrankenhaus Neuss
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Athens
country: Greece
facility: Athens Medical Center - Psychikon branch
state: Attikí
city: Athens
country: Greece
facility: University General Hospital "Attikon"
state: Chaidari
city: Heraklion
country: Greece
facility: "University General Hospital of Heraklion Oncology Unit "
state: Crete
city: Nea Efkarpia
country: Greece
facility: "Papageorgiou" General Hospital of Thessaloniki 2nd Internal Medicine/Oncology Clinic of Aristotle
state: Thessaloniki
city: Athens
country: Greece
facility: Evgenidion Clinic Agia Trias Oncology Department
city: Cork
country: Ireland
facility: Cork University Hospital,Department of Medical Onncology
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Dublin
country: Ireland
facility: St Vincents University Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
city: Monserrato
country: Italy
facility: Azienda Ospedaliera Universitaria Cagliari
state: Cagliari
city: Monserrato
country: Italy
facility: Farmacia AOU Cagliari - Presidio Ospedaliero ' Duilio Casula' di Monserrate
state: Cagliari
city: Avellino
country: Italy
facility: UOC Oncologia Medica - Dipartimento Onco Ematologico AORN San Giuseppe Moscati di Avellino
state: Campania
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino Farmacia
state: GE
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Tricase
country: Italy
facility: UOC Oncologia, Azienda Ospedaliera Cardinale Giovanni Panico
state: Lecce
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardy
city: Milano
country: Italy
facility: lstituto Europeo di Oncologia
state: Lombardy
city: Milano
country: Italy
facility: Niguarda Cancer Center Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
state: Lombardy
city: Napoli
country: Italy
facility: UMaCA U.O.S.D. Farmacia Ospedaliera
state: Naples
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: Other
city: Pisa
country: Italy
facility: Ospedale S Chiara Farmacia
state: Other
city: Verona
country: Italy
facility: Servizio Farmacia Azienda Ospedaliera Universitaria lntegrata (AOUI) di Verona
state: Other
city: Reggio Emilia
country: Italy
facility: Farmacia Sperimentazioni
state: RE
city: Catania
country: Italy
facility: UOC Oncologia Medica, ARNAS GARIBALDI - PRESIDIO OSPEDALIERO NESIMA
state: Sicily
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Firenze
country: Italy
facility: SODc Oncologia Medica e Clinica, AOU Careggi
state: Tuscany
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
state: Veneto
city: Foggia
country: Italy
facility: Struttura Semplice Dipartimentale di Oncologia Medica e Terapia Biomolecolare Azienda Ospedaliero
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori Farmacia
city: Milan
country: Italy
facility: lstituto Europeo di Oncologia Servizio Farmacia
city: Padova
country: Italy
facility: Istituto Oncologico Veneto-IRCCS Farmacia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo Farmacia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Reggio Emilia
country: Italy
facility: Farmacia UFA
city: Reggio Emilia
country: Italy
facility: S.C Oncologia Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Farmacia degli Sperimentali Policlinico Gemelli IRCCS
city: Sondrio
country: Italy
facility: ASST della Valtellina e dell'alto Lario - Presidio Ospedaliero di Sondrio
city: Sondrio
country: Italy
facility: ASST della Valtellina e dell'alto Lario- Presidio Ospedaliero di Sondrio Farmacia
city: Verona
country: Italy
facility: U.O.C. Oncologia Azienda Ospedaliera Universitaria lntegrata (AOUI) di Verona
city: Chiba-shi
country: Japan
facility: Chiba Cancer Center
state: Chiba-ken
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba-ken
city: Matsuyama-shi
country: Japan
facility: NHO Shikoku Cancer Center
state: Ehime-ken
city: Fukuoka-City
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
state: Hyōgo
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka-fu
city: Chuo-Ku
country: Japan
facility: National Hospital Organization Osaka National Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Other
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Nieuwegein
country: Netherlands
facility: Klinische Farmacie
city: Utrecht
country: Netherlands
facility: St. Antonius Ziekenhuis - Ziekenhuis Utrecht
city: Venlo
country: Netherlands
facility: Viecuri Medisch Centrum
city: Bergen
country: Norway
facility: Sjukehusapoteket i Bergen [Bergen Hospital Pharmacy]
city: Bergen
country: Norway
facility: Helse Bergen HF, Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital (OUH) - The Norwegian Radium Hospital
city: Oslo
country: Norway
facility: Sykehusapoteket Oslo, Radiumhospitalet-Avdeling Produksjon
city: Warszawa
country: Poland
facility: Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy lnstytut Badawczy
state: Mazowieckie
city: Warszawa
country: Poland
facility: Marii Sklodowskiej-Curie Panstwowy lnstytut Badawczy
state: Mazowieckie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny Klinika Onkologii
state: Mazowieckie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
state: Mazowieckie
city: Rzeszow
country: Poland
facility: MRUK-MED | Sp. z.o.o Apteka szpitalna
state: Podkarpackie
city: Rzeszow
country: Poland
facility: MRUK-MED | Sp. z.o.o
state: Podkarpackie
city: Gdansk
country: Poland
facility: Apteka Szpitalna Uniwersytie Centrum Kliniczne
state: Pomorskie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED Roman Karaszewski
state: Wielkopolskie
city: Lodz
country: Poland
facility: Salve Medica Apteka Szpitalna
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Guarda
country: Portugal
facility: Unidade Local de Saude da Guarda-Hospital Sousa Martins
city: Lisboa
country: Portugal
facility: Fundacao Champalimaud
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de Santo Antonio,E.P.E.
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky ustav II.Onkologicka Klinika LFUK a NOU
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals - Institut Catala d'Oncologia L'Hospitalet (ICO L'Hospitalet)
state: Barcelona
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra (Madrid)
state: Madrid, Comunidad DE
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: CETIR Viladomat
state: Other
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa CRUZ DE Tenerife
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Radiology: CETIR Ascires
city: Barcelona
country: Spain
facility: Data review: Vall d'Hebron institute of Oncology (VHIO).
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron Unidad de Farmacia de Ensayos Clinicos Oncohematologia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga (Hospital Civil)
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Quiron Salud Zaragoza
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Winterthur
country: Switzerland
facility: Pharmacy:Kantonsspital Winterthur
state: Other
city: Schlieren
country: Switzerland
facility: Zuripharm AG
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich - Klinik fur Medizinische Onkologie und Hamatologie USZ
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Clinical Trial Pharmacy
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital LinKou
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Chelsea
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust, Oncology Centre
state: England
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
state: Surrey
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust, st James's Institute of Oncology
city: London
country: United Kingdom
facility: Guy's and Saint Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden Hospital - Chelsea Site
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: