Spots Global Cancer Trial Database for A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
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Trial Identification
Brief Title: 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 ID: NCT05253651
Conditions
Study Description
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 test 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Palo Verde Cancer Specialists, Glendale, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Pacific Cancer Medical Center, Anaheim, California, United States
Los Angeles Cancer Network, Los Angeles, California, United States
Kaiser Permanente Southern California, Los Angeles, California, United States
University of Southern California, Los Angeles, California, United States
University of Southern California, Newport Beach, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Rocky Mountain Cancer Centers - Aurora, Denver, Colorado, United States
Mount Sinai Medical Center / Florida, Miami Beach, Florida, United States
Woodlands Medical Specialists, Pensacola, Florida, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
MidAmerica Cancer Center, LLC, Merriam, Kansas, United States
Baptist Health Lexington, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
HealthPartners Institute, Saint Louis Park, Minnesota, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
FirstHealth of the Carolinas, Pinehurst, North Carolina, United States
Gabrail Cancer Center Research, LLC, Canton, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Oncology - Baylor Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Texas Oncology - McKinney, McKinney, Texas, United States
Texas Oncology - Northeast Texas, Paris, Texas, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care, Roanoke, Virginia, United States
Providence Regional Medical Center Everett, Everett, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Hospital Britanico de Buenos Aires, Ciudad Autonoma Buenos Aires, Other, Argentina
Instituto Alexander Fleming, Ciudad Autonoma Buenos Aires, Other, Argentina
CEMAIC - Centro Medico Privado, Cordoba, Other, Argentina
Instituto Oncologico de Cordoba, Córdoba, Other, Argentina
Centro de Investigacion Pergamino SA, Pergamino, Other, Argentina
Instituto Medico de la Fundacion Estudios Clinicos, Rosario, Other, Argentina
St Vincent's Hospital Melbourne, Fitzroy, Other, Australia
The Alfred Hospital, Melbourne, Other, Australia
Townsville Cancer Center, Townsville, Other, Australia
Salzburg Cancer Research Institute, Salzburg, Other, Austria
Klinikum Wels-Grieskirchen GmbH, Wels, Other, Austria
Institut Jules Bordet, Anderlecht, Other, Belgium
Cliniques Universitaires Saint Luc, Brussels, Other, Belgium
Universitair Ziekenhuis Antwerpen, Edegem, Other, Belgium
Hopital de Jolimont, Haine-Saint-Paul, Other, Belgium
Centre Hospitalier Chretien - Clinique MontLegia, Liège, Other, Belgium
Az Turnhout, Turnhout, Other, Belgium
Hospital de Cancer de Barretos - Fundacao Pio XII, Barretos, Other, Brazil
CIONC-Centro Integrado de Oncologia de Curitiba, Curitiba, Other, Brazil
Fundacao Doutor Amaral Carvalho, Jaú, Other, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, Other, Brazil
Instituto COI de Pesquisa, Rio de Janeiro, Other, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo Andre, Other, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Sao Jose Rio Preto, Other, Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira, São Paulo, Other, Brazil
University of Ottawa / Ottawa General Hospital, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
BIOCENTER Centro Clinico de Investigacion, Concepción, Other, Chile
Centro de Estudios Clinicos SAGA, Santiago, Other, Chile
Oncocentro APYS, Viña del Mar, Other, Chile
Beijing Cancer Hospital, Beijing, Other, China
The Second Xiangya Hospital of Central South University, Changsha, Other, China
Hunan Cancer Hospital, Changsha, Other, China
Changzhou Tumor Hospital, Changzhou, Other, China
The First People's Hospital of Changzhou, Changzhou, Other, China
Affiliated Hospital of Chengde Medical University, Chengde, Other, China
Army Specialty Medical Center of The Chinese People's Liberation Army, Chongqing, Other, China
Fujian Medical University Union Hospital, Fuzhou, Other, China
900TH Hospital of Joint Logistics Support Force, Fuzhou, Other, China
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Other, China
The Second Affiliated Hospital of Hainan Medical University, Haikou, Other, China
Hainan General Hospital, Haikou, Other, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Other, China
Zhejiang University School of Medicine, Hangzhou, Other, China
Harbin Medical University Cancer Hospital, Harbin, Other, China
Jinan Central Hospital, Jinan, Other, China
Shandong Cancer Hospital, Jinan, Other, China
The First Hospital Affiliated to Liaoning Medical College, Jinzhou, Other, China
The First Hospital of Lanzhou University, Lanzhou, Other, China
Linyi Cancer Hospital, Linyi, Other, China
Meizhou People's Hospital - Guangdong Province, Meizhou, Other, China
The First Affiliated Hospital of Nanchang University, Nanchang, Other, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Other, China
Nanyang Second General Hospital, Nanyang, Other, China
Shanghai General Hospital, Shanghai, Other, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Other, China
The First Hospital of China Medical University, Shenyang, Other, China
Liaoning Cancer Hospital and Institute, Shenyang, Other, China
The First Affiliated Hospital of Soochow University, Suzhou, Other, China
Shanxi Province Cancer Hospital, Taiyuan, Other, China
Tangshan People's Hospital, Tangshan, Other, China
Hubei Cancer Hospital, Wuhan, Other, China
Xuzhou Central Hospital, Xuzhou, Other, China
Henan Provincial People's Hospital, Zhengzhou, Other, China
Sainte Catherine Institut du Cancer Avignon Provence, Avignon, Other, France
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz, Besancon Cedex, Other, France
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan, Brest Cedex, Other, France
Center Georges Francois Leclerc, Dijon, Other, France
Hospital Edouard Herriot (HEH), Lyon, Other, France
Hopital Saint Joseph de Marseille, Marseille, Other, France
Centre Hospitalier Universitaire Nantes-Hotel Dieu, Nantes, Other, France
Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne, Nice Cedex 2, Other, France
Hopital Saint Louis, APHP, Paris Cedex 10, Other, France
Hopital Saint-Antoine, Paris, Other, France
Hopital Europeen Georges Pompidou, Paris, Other, France
CHU Bordeaux Hopital Haut-Leveque, Pessac, Other, France
Centre Hospitalier Universitaire de Poitiers, Poitiers, Other, France
CHU de Rouen, Rouen, Other, France
CHU Saint Etienne Hopital Nord, Saint-Priest en Jarez, Other, France
Institut de Cancerologie de I'Ouest - Site Saint-Herblain, St Herblain, Other, France
Institut de cancerologie Strasbourg Europe, Strasbourg, Other, France
Gemeinschaftspraxis Haematologie - Onkologie: Freiberg-Richter, Jacobasch, Illmer, Wolf, Dresden, Other, Germany
Universitaetsklinikum Carl Gustav Carus Dresden, Dresden, Other, Germany
Medizinische Hochschule Hannover, Hannover, Other, Germany
Kliniken Maria Hilf GmbH, Mönchengladbach, Other, Germany
LMU - Klinikum der Universitaet Muenchen - Campus Grosshadern - Medizinische Klinik und Poliklinik III, München, Other, Germany
Evgenidion Clinic Agia Trias, Athens, Other, Greece
Tolna Varmegyei Balassa Janos Korhaz, Szekszard, Other, Hungary
Bon Secours Hospital Cork, Cork, Other, Ireland
Mater Misericordiae University Hospital (MMUH), Dublin, Other, Ireland
Beaumont Hospital, Dublin, Other, Ireland
University Hospital Waterford, Waterford, Other, Ireland
Cork University Hospital, Wilton, Other, Ireland
Mater Private Hospital (MPH), Dublin, , Ireland
Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Other, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Presido Ospedale Garibaldi - Nesima, Catania, Other, Italy
University of Foggia, Riuniti Hospital, Foggia, Other, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Other, Italy
Istituto Europeo di Oncologia, Milano, Other, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, Other, Italy
Azienda Ospedaliera Universitaria Cagliari, Monserrato, Other, Italy
Istituto Oncologico Veneto - IRCCS, Padova, Other, Italy
IRCSS Policlinico San Matteo, Pavia, Other, Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, Other, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSU, Roma, Other, Italy
ASST Valtellina e Alto Lario, Sondrio, Other, Italy
Azienda Ospedaliera Cardinale Giovanni Panico, Tricase, Other, Italy
Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Other, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Avellino, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
Chiba Cancer Center, Chiba, Other, Japan
National Cancer Center Hospital, Chuo-ku, Other, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, Other, Japan
National Cancer Center Hospital East, Kashiwa-shi, Other, Japan
St. Marianna University School of Medicine, Kawasaki-shi, Other, Japan
Kagawa University Hospital, Kita-gun, Other, Japan
Saitama Cancer Center, Kitaadachi-gun, Other, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital, Kobe-shi, Other, Japan
The Cancer Institute Hospital of JFCR, Koto-ku, Other, Japan
NHO Shikoku Cancer Center, Matsuyama-shi, Other, Japan
National Hospital Organization Osaka, Osaka-shi, Other, Japan
Osaka General Medical Center (Kyuseiki Sogo Iryo C), Osaka-shi, Other, Japan
Kindai University Hospital, Osakasayama-Shi, Other, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo-shi, Other, Japan
Osaka University Hospital, Suita-shi, Other, Japan
Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi, Other, Japan
Kanagawa Cancer Center, Yokohama, Other, Japan
Gachon University Gil Medical Center, Incheon, Other, Korea, Republic of
Korea University Anam Hospital, Seoul, Other, Korea, Republic of
Seoul National University Hospital, Seoul, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Other, Korea, Republic of
Asan Medical Center - Oncology, Seoul, Other, Korea, Republic of
Korea University Guro Hospital, Seoul, Other, Korea, Republic of
Samsung Medical Center, Seoul, Other, Korea, Republic of
Netherlands Cancer Institute, Amsterdam, Other, Netherlands
St. Antonius Hospital, Nieuwegein, Other, Netherlands
VieCuri Medisch Centrum, Venlo, Other, Netherlands
Haukeland Universitetssjukehus, Bergen, Other, Norway
Oslo University Hospital, Oslo, Other, Norway
Katedra i Klinika Onkologii i Radioterapii, Gdansk, Other, Poland
Przychodnia Lekarska KOMED Roman Karaszewski, Konin, Other, Poland
Salve Medica, Lodz, Other, Poland
Mruk-Med - Sp. z o.o., Rzeszow, Other, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Warsaw, Other, Poland
Hospital Sousa Martins, Guarda, Other, Portugal
The Champalimaud Centre for the Unknown, Lisboa, Other, Portugal
Centro Hospitalar Universitario do Porto - Hospital Geral de Santo Antonio, Porto, Other, Portugal
Narodny Onkologicky Ustav, Bratislava, Other, Slovakia
POKO Poprad, Poprad, Other, Slovakia
Hospital General Universitario Alicante, Alicante, Other, Spain
Hospital Universitari Vall d'Hebron, Barcelona, Other, Spain
Hospital Clinic de Barcelona, Barcelona, Other, Spain
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, Other, Spain
Hospital Universitario Reina Sofia, Cordoba, Other, Spain
Hospital Universitari Arnau de Vilanova, Lleida, Other, Spain
Hospital General Universitario Gregorio Maranon, Madrid, Other, Spain
Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos, Madrid, Other, Spain
Hospital Universitario 12 de Octubre, Madrid, Other, Spain
Hospital Universitario La Paz, Madrid, Other, Spain
Hospital Regional Universitario de Malaga - Hospital General, Malaga, Other, Spain
Complejo Hospitalario Universitario de Ourense (CHOU), Ourense, Other, Spain
Hospital Universitario Central de Asturias, Oviedo, Other, Spain
Complejo Hospitalario de Navarra, Pamplona, Other, Spain
Hospital Universitario Marques de Valdecilla, Santander, Other, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Other, Spain
Consorci Hospital General Universitari de Valencia (CHGUV), Valencia, Other, Spain
Hospital Universitario Miguel Servet, Zaragoza, Other, Spain
Kantonsspital Winterthur (KSW), Winterthur, Other, Switzerland
Universitatsspital Zurich, Zurich, Other, Switzerland
Chang Gung Memorial Hospital - Kaohsiung, Kaohsiung City, Other, Taiwan
National Cheng-Kung University Hospital, Tainan, Other, Taiwan
Taipei Veterans General Hospital, Taipei City, Other, Taiwan
National Taiwan University Hospital, Taipei, Other, Taiwan
Chang Gung Memorial Hospital - Linkou, Taoyuan, Other, Taiwan
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, Other, United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Cambridge, Other, United Kingdom
Hull University Teaching Hospitals NHS Trust, Cottingham, Other, United Kingdom
Leeds Teaching Hospitals Trust, Leeds, Other, United Kingdom
Guy's and St Thomas' NHS Foundation, London, Other, United Kingdom
Imperial College Healthcare NHS Trust, London, Other, United Kingdom
The Christie NHS Foundation Trust, Manchester, Other, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, Other, United Kingdom
Contact Details
Name: Medical Monitor
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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