A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)

April 12, 2024 updated by: Seagen Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Other
      • Ciudad Autonoma Buenos Aires, Other, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming
        • Principal Investigator:
          • Juan O'Connor
      • Ciudad Autonoma Buenos Aires, Other, Argentina, C1280AEB
        • Recruiting
        • Hospital Britanico de Buenos Aires
        • Principal Investigator:
          • Luciana Bella Quero
      • Cordoba, Other, Argentina, X5008HHW
        • Recruiting
        • CEMAIC - Centro Medico Privado
        • Principal Investigator:
          • Jorge Emilio Salinas
      • Córdoba, Other, Argentina, X5006HBF
        • Recruiting
        • Instituto Oncologico de Cordoba
        • Principal Investigator:
          • Eduardo Richardet
      • Pergamino, Other, Argentina, B2700CPM
        • Recruiting
        • Centro de Investigacion Pergamino SA
        • Principal Investigator:
          • Jesica Monzon
      • Rosario, Other, Argentina, S2000DEJ
        • Recruiting
        • Instituto Medico de la Fundacion Estudios Clinicos
        • Principal Investigator:
          • Gabriel Garbaos
  • Australia
    • Other
      • Fitzroy, Other, Australia, 3065
        • Recruiting
        • St Vincent's Hospital Melbourne
        • Principal Investigator:
          • Sue-Anne McLachlan
      • Melbourne, Other, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Principal Investigator:
          • Benjamin Markman
      • Townsville, Other, Australia, 4814
        • Recruiting
        • Townsville Cancer Center
        • Principal Investigator:
          • Nathan Theodore Bain
  • Austria
    • Other
      • Salzburg, Other, Austria, 5020
        • Recruiting
        • Salzburg Cancer Research Institute
        • Principal Investigator:
          • Richard Greil
      • Wels, Other, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen GmbH
        • Principal Investigator:
          • Josef Thaler
  • Belgium
    • Other
      • Anderlecht, Other, Belgium, B-1070
        • Recruiting
        • Institut Jules Bordet
        • Principal Investigator:
          • Francesco Sclafani
      • Brussels, Other, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint Luc
        • Principal Investigator:
          • Marc Van den Eynde
      • Edegem, Other, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Principal Investigator:
          • Hans Prenen, MD
      • Haine-Saint-Paul, Other, Belgium, 7100
        • Recruiting
        • Hopital de Jolimont
        • Principal Investigator:
          • Alexandre Dermine
      • Liège, Other, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Chretien - Clinique MontLegia
        • Principal Investigator:
          • Ghislain Houbiers
      • Turnhout, Other, Belgium, 2300
        • Recruiting
        • Az Turnhout
        • Principal Investigator:
          • Leen Simonne Mortier
  • Brazil
    • Other
      • Barretos, Other, Brazil, 14784-400
        • Recruiting
        • Hospital de Cancer de Barretos - Fundacao Pio XII
        • Principal Investigator:
          • Marcelo Souza Drude
      • Curitiba, Other, Brazil, 80810-050
        • Recruiting
        • CIONC-Centro Integrado de Oncologia de Curitiba
        • Principal Investigator:
          • Karina Costa Maia Vianna
      • Jaú, Other, Brazil, 17210-120
        • Recruiting
        • Fundacao Doutor Amaral Carvalho
        • Principal Investigator:
          • Patricia Medeiros Milhomem Beato
      • Porto Alegre, Other, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceicao
        • Principal Investigator:
          • Gustavo Vasconcelos Alves
      • Rio de Janeiro, Other, Brazil, 22793-080
        • Recruiting
        • Instituto COI de Pesquisa
        • Principal Investigator:
          • Fernando Meton de Alencar Camara Vieira
      • Santo Andre, Other, Brazil, 09060-870
        • Recruiting
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
        • Principal Investigator:
          • Daniel Cubero
      • Sao Jose Rio Preto, Other, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
        • Principal Investigator:
          • Kathia Abdalla
      • São Paulo, Other, Brazil, 01246-000
        • Recruiting
        • ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
        • Principal Investigator:
          • Camila Motta Venchiarutti Moniz
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • University of Ottawa / Ottawa General Hospital
        • Principal Investigator:
          • Rachel Goodwin
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Principal Investigator:
          • Sheron Perera
      • Toronto, Ontario, Canada, M5G1X2
        • Recruiting
        • Mount Sinai Hospital - Toronto
        • Principal Investigator:
          • Ronald Burkes
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Principal Investigator:
          • Petr Kavan
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Recruiting
        • Saskatoon Cancer Centre
        • Principal Investigator:
          • Osama Ahmed
  • Chile
    • Other
      • Concepción, Other, Chile, 4070268
        • Recruiting
        • BIOCENTER Centro Clinico de Investigacion
        • Principal Investigator:
          • Esther Rodriguez De Vasquez
      • Santiago, Other, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clinicos SAGA
        • Principal Investigator:
          • Marcelo Adan Garrido Salvo
      • Viña del Mar, Other, Chile, 2520598
        • Recruiting
        • Oncocentro APYS
        • Principal Investigator:
          • Alejandro Acevedo Gaete
  • China
    • Other
      • Beijing, Other, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Principal Investigator:
          • Lin Shen
      • Changsha, Other, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Xianli Yin
      • Changsha, Other, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Principal Investigator:
          • Yawen Gao
      • Changzhou, Other, China, 213002
        • Recruiting
        • Changzhou Tumor Hospital
        • Principal Investigator:
          • Yang Ling
      • Changzhou, Other, China, 213003
        • Recruiting
        • The First People's Hospital of Changzhou
        • Principal Investigator:
          • Xuefeng Ni
      • Chengde, Other, China, 067000
        • Recruiting
        • Affiliated Hospital of Chengde Medical University
        • Principal Investigator:
          • Qingshan Li
      • Chongqing, Other, China, 400042
        • Recruiting
        • Army Specialty Medical Center of The Chinese People's Liberation Army
        • Principal Investigator:
          • Mengxia Li
      • Fuzhou, Other, China, 350025
        • Recruiting
        • 900TH Hospital of Joint Logistics Support Force
        • Principal Investigator:
          • Xi Chen
      • Fuzhou, Other, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Principal Investigator:
          • Dongta Zhong
      • Guangzhou, Other, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Principal Investigator:
          • Yanhong Deng
      • Haikou, Other, China, 570311
        • Recruiting
        • Hainan General Hospital
        • Principal Investigator:
          • Lin Wang
      • Haikou, Other, China, 570100
        • Recruiting
        • The Second Affiliated Hospital of Hainan Medical University
        • Principal Investigator:
          • Haifeng Lin
      • Hangzhou, Other, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Ying Yuan
      • Hangzhou, Other, China, 310016
        • Recruiting
        • Zhejiang University School of Medicine
        • Principal Investigator:
          • Hongming Pan
      • Harbin, Other, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Yuxian Bai
      • Jinan, Other, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • Meili Sun
      • Jinan, Other, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Principal Investigator:
          • Zuoxing Niu
      • Jinzhou, Other, China, 121001
        • Recruiting
        • The First Hospital Affiliated to Liaoning Medical College
        • Principal Investigator:
          • Zhitu Zhu
      • Lanzhou, Other, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Principal Investigator:
          • Shoucheng Ma
      • Linyi, Other, China, 276000
        • Recruiting
        • Linyi Cancer Hospital
        • Principal Investigator:
          • Zhen Li
      • Meizhou, Other, China, 514031
        • Recruiting
        • Meizhou People's Hospital - Guangdong Province
        • Principal Investigator:
          • Xiwen Huang
      • Nanchang, Other, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Hua Wang
      • Nanchang, Other, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Jianping Xiong
      • Nanyang, Other, China, 473009
        • Recruiting
        • Nanyang Second General Hospital
        • Principal Investigator:
          • Xianzhe Yin
      • Shanghai, Other, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Principal Investigator:
          • Jianhua Chen
      • Shanghai, Other, China, 200092
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Wei Chen
      • Shenyang, Other, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Principal Investigator:
          • Xiujuan Qu
      • Shenyang, Other, China, 110042
        • Recruiting
        • Liaoning Cancer Hospital and Institute
        • Principal Investigator:
          • Jingdong Zhang
      • Suzhou, Other, China, 215004
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Kai Chen
      • Taiyuan, Other, China, 30013
        • Recruiting
        • Shanxi Province Cancer Hospital
        • Principal Investigator:
          • Yusheng Wang
      • Tangshan, Other, China, 06300
        • Recruiting
        • Tangshan People's Hospital
        • Principal Investigator:
          • Zhiwu Wang
      • Wuhan, Other, China, 430000
        • Recruiting
        • Hubei Cancer Hospital
        • Principal Investigator:
          • Xinjun Liang
      • Xuzhou, Other, China, 221009
        • Recruiting
        • Xuzhou Central Hospital
        • Principal Investigator:
          • Yuan Yuan
      • Zhengzhou, Other, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Principal Investigator:
          • Shundong Cang
  • France
    • Other
      • Avignon, Other, France, 84000
        • Recruiting
        • Sainte Catherine Institut du Cancer Avignon Provence
        • Principal Investigator:
          • Laurent Mineur
      • Besancon Cedex, Other, France, 25000
        • Recruiting
        • Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
        • Principal Investigator:
          • Christophe Borg
      • Brest Cedex, Other, France, 29609
        • Recruiting
        • Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan
        • Principal Investigator:
          • Jean-philippe Metges
      • Dijon, Other, France, 21000
        • Recruiting
        • Center Georges Francois Leclerc
        • Principal Investigator:
          • Francois Ghiringhelli
      • Lyon, Other, France, 69003
        • Recruiting
        • Hospital Edouard Herriot (HEH)
        • Principal Investigator:
          • Julien Forestier
      • Marseille, Other, France, 13008
        • Recruiting
        • Hopital Saint Joseph de Marseille
        • Principal Investigator:
          • Herve Perrier
      • Nantes, Other, France, 44000
        • Recruiting
        • Centre Hospitalier Universitaire Nantes-Hotel Dieu
        • Principal Investigator:
          • Yann Touchefeu
      • Nice Cedex 2, Other, France, 06189
        • Recruiting
        • Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
        • Principal Investigator:
          • Ludovic Evesque
      • Paris, Other, France, 75012
        • Recruiting
        • Hopital Saint-Antoine
        • Principal Investigator:
          • Thierry Andre
      • Paris, Other, France, 75015
        • Recruiting
        • Hopital Europeen Georges Pompidou
        • Principal Investigator:
          • Claire Gallois
      • Paris Cedex 10, Other, France, 75475
        • Recruiting
        • Hopital Saint Louis, APHP
        • Principal Investigator:
          • Thomas Aparicio
      • Pessac, Other, France, 33604
        • Recruiting
        • CHU Bordeaux Hopital Haut-Leveque
        • Principal Investigator:
          • Denis Smith
      • Poitiers, Other, France, 86000
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Principal Investigator:
          • David Tougeron
      • Rouen, Other, France, 76031
        • Recruiting
        • CHU de Rouen
        • Principal Investigator:
          • Frederic Di Fiore
      • Saint-Priest en Jarez, Other, France, 42270
        • Recruiting
        • CHU Saint Etienne Hopital Nord
        • Principal Investigator:
          • Jean-Marc Phelip
      • St Herblain, Other, France, 44805
        • Recruiting
        • Institut de Cancerologie de I'Ouest - Site Saint-Herblain
        • Principal Investigator:
          • Judith Raimbourg
      • Strasbourg, Other, France, 67033
        • Recruiting
        • Institut de cancerologie Strasbourg Europe
        • Principal Investigator:
          • Meher Ben Abdelghani
  • Germany
    • Other
      • Dresden, Other, Germany, 01307
        • Recruiting
        • Gemeinschaftspraxis Haematologie - Onkologie: Freiberg-Richter, Jacobasch, Illmer, Wolf
        • Principal Investigator:
          • Lutz Jacobasch
      • Hannover, Other, Germany, D-30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Anna Lena Saborowski
      • Mönchengladbach, Other, Germany, 41063
        • Recruiting
        • Kliniken Maria Hilf GmbH
        • Principal Investigator:
          • Ullrich Graeven
      • München, Other, Germany, 81377
        • Recruiting
        • LMU - Klinikum der Universitaet Muenchen - Campus Grosshadern - Medizinische Klinik und Poliklinik III
        • Principal Investigator:
          • Volker Heinemann
  • Greece
    • Other
      • Athens, Other, Greece, 115 28
        • Recruiting
        • Evgenidion Clinic Agia Trias
        • Principal Investigator:
          • Michalis Karamouzis
  • Ireland
      • Dublin, Ireland, D07 WKW8
        • Recruiting
        • Mater Private Hospital (MPH)
        • Principal Investigator:
          • John McCaffrey
    • Other
      • Cork, Other, Ireland, T12NY9K
        • Recruiting
        • Bon Secours Hospital Cork
        • Principal Investigator:
          • Brian Bird
      • Dublin, Other, Ireland, D09 AOEA
        • Recruiting
        • Beaumont Hospital
        • Principal Investigator:
          • Adrian Murphy
      • Dublin, Other, Ireland, D07 R2WY
        • Recruiting
        • Mater Misericordiae University Hospital (MMUH)
        • Principal Investigator:
          • John McCaffrey
        • Principal Investigator:
          • Darren Cowzer
      • Waterford, Other, Ireland, X91 ER8E
        • Recruiting
        • University Hospital Waterford
        • Principal Investigator:
          • Anne Horgan
      • Wilton, Other, Ireland, T12 E8YV
        • Recruiting
        • Cork University Hospital
        • Principal Investigator:
          • Derek Power
  • Italy
      • Avellino, Italy, 83100
        • Recruiting
        • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione
        • Principal Investigator:
          • Giuseppe Santabarbara
      • Firenze, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi
        • Principal Investigator:
          • Lorenzo Antonuzzo
    • Other
      • Brescia, Other, Italy, 25124
        • Recruiting
        • Fondazione Poliambulanza Istituto Ospedaliero
        • Principal Investigator:
          • Alberto Zaniboni
      • Catania, Other, Italy, 95122
        • Recruiting
        • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Presido Ospedale Garibaldi - Nesima
        • Principal Investigator:
          • Roberto Bordonaro
      • Foggia, Other, Italy, 71122
        • Recruiting
        • University of Foggia, Riuniti Hospital
        • Principal Investigator:
          • Matteo Landriscina
      • Milano, Other, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Principal Investigator:
          • Maria Giulia Zampino
      • Milano, Other, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Principal Investigator:
          • Filippo Pietrantonio
      • Milano, Other, Italy, 20162
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
        • Principal Investigator:
          • Salvatore Siena
      • Monserrato, Other, Italy, 09042
        • Recruiting
        • Azienda Ospedaliera Universitaria Cagliari
        • Principal Investigator:
          • Mario Scartozzi
      • Padova, Other, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto - IRCCS
        • Principal Investigator:
          • Sara Lonardi
      • Pavia, Other, Italy, 27100
        • Recruiting
        • IRCSS Policlinico San Matteo
        • Principal Investigator:
          • Anna Pagani
      • Pisa, Other, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Principal Investigator:
          • Chiara Cremolini
      • Roma, Other, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCSU
        • Principal Investigator:
          • Giampaolo Tortora
      • Sondrio, Other, Italy, 23100
        • Recruiting
        • ASST Valtellina e Alto Lario
        • Principal Investigator:
          • Alessandro Bertolini
      • Tricase, Other, Italy, 73039
        • Recruiting
        • Azienda Ospedaliera Cardinale Giovanni Panico
        • Principal Investigator:
          • Emiliano Tamburini
      • Verona, Other, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata di Verona
        • Principal Investigator:
          • Michele Milella
  • Japan
    • Other
      • Chiba, Other, Japan, 260-8717
        • Recruiting
        • Chiba Cancer Center
        • Principal Investigator:
          • Denda Tadamichi
      • Chuo-ku, Other, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Principal Investigator:
          • Atsuo Takashima
      • Fukuoka-shi, Other, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
        • Principal Investigator:
          • Taito Esaki
      • Kashiwa-shi, Other, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Principal Investigator:
          • Yoshiaki Nakamura
      • Kawasaki-shi, Other, Japan, 2168511
        • Recruiting
        • St. Marianna University School of Medicine
        • Principal Investigator:
          • Yu Sunakawa
      • Kita-gun, Other, Japan, 761-0793
        • Recruiting
        • Kagawa University Hospital
        • Principal Investigator:
          • Akihito Tsuji
      • Kitaadachi-gun, Other, Japan, 362-0806
        • Recruiting
        • Saitama Cancer Center
        • Principal Investigator:
          • Masako Asayama
      • Kobe-shi, Other, Japan, 650-0047
        • Recruiting
        • Kobe City Hospital Organization Kobe City Medical Center General Hospital
        • Principal Investigator:
          • Hisateru Yasui
      • Koto-ku, Other, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital of JFCR
        • Principal Investigator:
          • Kensei Yamaguchi
      • Matsuyama-shi, Other, Japan, 791-0280
        • Recruiting
        • NHO Shikoku Cancer Center
        • Principal Investigator:
          • Tomohiro Nishina
      • Osaka-shi, Other, Japan, 558-8558
        • Recruiting
        • Osaka General Medical Center (Kyuseiki Sogo Iryo C)
        • Principal Investigator:
          • Yujiro Nishizawa
      • Osaka-shi, Other, Japan, 540-0006
        • Recruiting
        • National Hospital Organization Osaka
        • Principal Investigator:
          • Takeshi Kato
      • Osakasayama-Shi, Other, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital
        • Principal Investigator:
          • Hisato Kawakami
      • Sapporo-shi, Other, Japan, 060-8648
        • Recruiting
        • National Hospital Organization Hokkaido Cancer Center
        • Principal Investigator:
          • Yoshito Komatsu
      • Suita-shi, Other, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
        • Principal Investigator:
          • Taroh Satoh
      • Takatsuki-shi, Other, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Principal Investigator:
          • Toshifumi Yamaguchi
      • Yokohama, Other, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center
        • Principal Investigator:
          • Nozomu Machida
  • Korea, Republic of
    • Other
      • Incheon, Other, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • SunJin Sym
      • Seoul, Other, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Han Sang Kim
      • Seoul, Other, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center - Oncology
        • Principal Investigator:
          • Sun Young Kim
      • Seoul, Other, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Sae-Won Han
      • Seoul, Other, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • SooHyeon Lee
      • Seoul, Other, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Principal Investigator:
          • Sang Cheul Oh
      • Seoul, Other, Korea, Republic of, 6351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Seung Tae Kim
  • Netherlands
    • Other
      • Amsterdam, Other, Netherlands, 1066 WX
        • Recruiting
        • Netherlands Cancer Institute
        • Principal Investigator:
          • Myriam Chalabi
      • Nieuwegein, Other, Netherlands, 3435 CM
        • Recruiting
        • St. Antonius Hospital
        • Principal Investigator:
          • Maartje Los
      • Venlo, Other, Netherlands, 5912 BL
        • Recruiting
        • VieCuri Medisch Centrum
        • Principal Investigator:
          • Hanneke Vestjens
  • Norway
    • Other
      • Bergen, Other, Norway, 5021
        • Recruiting
        • Haukeland Universitetssjukehus
        • Principal Investigator:
          • Inger Marie Loes
      • Oslo, Other, Norway, 0450
        • Recruiting
        • Oslo University Hospital
        • Principal Investigator:
          • Jorgen Smeby
  • Poland
    • Other
      • Gdansk, Other, Poland, 80-214
        • Recruiting
        • Katedra i Klinika Onkologii i Radioterapii
        • Principal Investigator:
          • Ewa Szutowicz
      • Konin, Other, Poland, 62-500
        • Recruiting
        • Przychodnia Lekarska KOMED Roman Karaszewski
        • Principal Investigator:
          • Boguslawa Karaszewska
      • Lodz, Other, Poland, 91-211
        • Recruiting
        • Salve Medica
        • Principal Investigator:
          • Monika Kukulska
      • Warsaw, Other, Poland, 02-034
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
        • Principal Investigator:
          • Lucjan Wyrwicz, MD
  • Portugal
    • Other
      • Guarda, Other, Portugal, 6300-035
        • Recruiting
        • Hospital Sousa Martins
        • Principal Investigator:
          • Maria Ines Sequeira
      • Lisboa, Other, Portugal, 1400-038
        • Recruiting
        • The Champalimaud Centre for the Unknown
        • Principal Investigator:
          • Nuno Couto
      • Porto, Other, Portugal, 4099-001
        • Recruiting
        • Centro Hospitalar Universitario do Porto - Hospital Geral de Santo Antonio
        • Principal Investigator:
          • Sergio Azevedo
  • Slovakia
    • Other
      • Bratislava, Other, Slovakia, 83100
        • Recruiting
        • Narodny Onkologicky Ustav
        • Principal Investigator:
          • Stefan Porsok
      • Poprad, Other, Slovakia, 058 01
        • Recruiting
        • POKO Poprad
        • Principal Investigator:
          • Juraj Beniak
  • Spain
    • Other
      • Alicante, Other, Spain, 03010
        • Recruiting
        • Hospital General Universitario Alicante
        • Principal Investigator:
          • Ana Lucia Yuste Izquierdo
      • Barcelona, Other, Spain, 08908
        • Recruiting
        • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
        • Principal Investigator:
          • Cristina Santos Vivas
      • Barcelona, Other, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Principal Investigator:
          • Joan Maurel Santasusana
      • Barcelona, Other, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Maria Elena Elez Fernandez
      • Cordoba, Other, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Principal Investigator:
          • Gema Guadalupe Pulido Cortijo
      • Lleida, Other, Spain, 25198
        • Recruiting
        • Hospital Universitari Arnau de Vilanova
        • Principal Investigator:
          • Maria Antonia Salud Salvia
      • Madrid, Other, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Cristina Gravalos Castro
      • Madrid, Other, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Nuria Rodriguez Salas
      • Madrid, Other, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Principal Investigator:
          • Pilar Garcia Alfonso
      • Madrid, Other, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos
        • Principal Investigator:
          • Maria Reyes Ferreiro Monteagudo
      • Malaga, Other, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga - Hospital General
        • Principal Investigator:
          • Julia Alcaide Garcia
      • Ourense, Other, Spain, 32005
        • Recruiting
        • Complejo Hospitalario Universitario de Ourense (CHOU)
        • Principal Investigator:
          • Ana Fernandez Montes
      • Oviedo, Other, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Principal Investigator:
          • Paula Jimenez Fonseca
      • Pamplona, Other, Spain, 31008
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Principal Investigator:
          • Ruth Vera Garcia
      • Santander, Other, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Principal Investigator:
          • Fernando Rivera Herrero
      • Sevilla, Other, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
        • Principal Investigator:
          • Manuel Jesus Valladares Ayerbes
      • Valencia, Other, Spain, 46014
        • Recruiting
        • Consorci Hospital General Universitari de Valencia (CHGUV)
        • Principal Investigator:
          • Maria Jose Safont Aguilera
      • Zaragoza, Other, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Principal Investigator:
          • Vicente Alonso Orduna
  • Switzerland
    • Other
      • Winterthur, Other, Switzerland, 8400
        • Recruiting
        • Kantonsspital Winterthur (KSW)
        • Principal Investigator:
          • Sabina Schacher
      • Zurich, Other, Switzerland, CH-8091
        • Recruiting
        • Universitatsspital Zurich
        • Principal Investigator:
          • Ralph Fritsch
  • Taiwan
    • Other
      • Kaohsiung City, Other, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital - Kaohsiung
        • Principal Investigator:
          • Hong-Hwa Chen
      • Tainan, Other, Taiwan, 704
        • Recruiting
        • National Cheng-Kung University Hospital
        • Principal Investigator:
          • Yu-Min Yeh
      • Taipei, Other, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Kun-Huei Yeh
      • Taipei City, Other, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Hao-Wei Teng
      • Taoyuan, Other, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital - Linkou
        • Principal Investigator:
          • Hung-Chih Hsu
  • United Kingdom
    • Other
      • Bristol, Other, United Kingdom, BS2 8ED
        • Recruiting
        • University Hospitals Bristol and Weston NHS Foundation Trust
        • Principal Investigator:
          • Stephen John Falk
      • Cottingham, Other, United Kingdom, HU16 5JQ
        • Completed
        • Hull University Teaching Hospitals NHS Trust
      • Leeds, Other, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Teaching Hospitals Trust
        • Principal Investigator:
          • Jenny Seligmann
      • London, Other, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and St Thomas' NHS Foundation
        • Principal Investigator:
          • Paul Ross
      • London, Other, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Principal Investigator:
          • Harpreet Wasan
      • Manchester, Other, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust
        • Principal Investigator:
          • Saifee Mullamitha
      • Newcastle upon Tyne, Other, United Kingdom, NE7 7DN
        • Recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Michelle Louise Cunnell
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Recruiting
        • Palo Verde Cancer Specialists
        • Contact:
        • Principal Investigator:
          • Amol Rakkar
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
        • Principal Investigator:
          • Tanios Bekaii-Saab
    • California
      • Anaheim, California, United States, 92801-1830
        • Recruiting
        • Pacific Cancer Medical Center
        • Principal Investigator:
          • Veena Charu
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Heinz-Josef Lenz
        • Contact:
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Los Angeles Cancer Network
        • Contact:
        • Principal Investigator:
          • Sungwon Rachel Kyung
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Southern California
        • Contact:
        • Principal Investigator:
          • Gary Buchschacher Jr.
      • Newport Beach, California, United States, 92663
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Heinz-Josef Lenz
      • Santa Rosa, California, United States, 95403
        • Completed
        • Providence Medical Foundation
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers - Aurora
        • Principal Investigator:
          • Allen Cohn
        • Contact:
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center / Florida
        • Contact:
        • Principal Investigator:
          • Mike Cusnir
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Woodlands Medical Specialists
        • Contact:
        • Principal Investigator:
          • Michael Poiesz
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute / Emory University School of Medicine
        • Principal Investigator:
          • Olumide Gbolahan
        • Contact:
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Winship Cancer Institute / Emory University School of Medicine
        • Principal Investigator:
          • Olumide Gbolahan
    • Kansas
      • Merriam, Kansas, United States, 66204
        • Recruiting
        • MidAmerica Cancer Center, LLC
        • Principal Investigator:
          • Jaswinder Singh
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
        • Principal Investigator:
          • Lee Hicks
        • Contact:
      • Louisville, Kentucky, United States, 40217
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Principal Investigator:
          • Zhaohui Jin
        • Contact:
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • HealthPartners Institute
        • Principal Investigator:
          • Yan Ji
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Andrea Cercek
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • John H Strickler
        • Contact:
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth of the Carolinas
        • Contact:
        • Principal Investigator:
          • Charles Kuzma
    • Ohio
      • Canton, Ohio, United States, 44718
        • Completed
        • Gabrail Cancer Center Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Evthokia Hobbs
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Evthokia Hobbs
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
        • Principal Investigator:
          • Heidi McKean
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Vanderbilt Clinical Trials Inbox
          • Phone Number: 800-811-8480
          • Email: cip@vumc.org
        • Principal Investigator:
          • Kristen K Ciombor, MD
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - Baylor Sammons Cancer Center
        • Principal Investigator:
          • Andrew David McCollum, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center / University of Texas
        • Contact:
        • Principal Investigator:
          • Kanwal Raghav
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Texas Oncology - McKinney
        • Principal Investigator:
          • Monte Jones
        • Contact:
      • Paris, Texas, United States, 75460
        • Recruiting
        • Texas Oncology - Northeast Texas
        • Contact:
        • Principal Investigator:
          • Sucharu Prakash
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
        • Principal Investigator:
          • Mark Kochenderfer
        • Contact:
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Medical Center Everett
        • Principal Investigator:
          • Amir Mehrvarz Sarshekeh, MD
        • Contact:
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Northwest Cancer Specialists, P.C.
        • Contact:
        • Principal Investigator:
          • David Cosgrove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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
  • GI perforation within 12 months of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tucatinib Arm
Tucatinib + trastuzumab + mFOLFOX6
Drug: tucatinib
300mg given by mouth (orally) twice daily
Other Names:
  • TUKYSA, ONT-380, ARRY-380
Drug: trastuzumab
8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.
Other Names:
  • Herceptin
Drug: oxaliplatin
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.
Drug: leucovorin
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.
Drug: levoleucovorin
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.
Drug: fluorouracil
400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.
Active Comparator: Standard of Care Arm
mFOLFOX6 + (bevacizumab OR cetuximab). Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab
Drug: oxaliplatin
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.
Drug: leucovorin
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.
Drug: levoleucovorin
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.
Drug: fluorouracil
400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.
Drug: bevacizumab
5mg/kg given by IV every 2 weeks
Other Names:
  • Avastin
Drug: cetuximab
400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly
Other Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 3 years
The time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 6 years
The time from randomization to death from any cause
Up to approximately 6 years
PFS per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
Up to approximately 3 years
Duration of response (DOR) per RECIST v1.1 by BICR
Time Frame: Up to approximately 3 years
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause
Up to approximately 3 years
DOR per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause
Up to approximately 3 years
Time to second progression or death (PFS2)
Time Frame: Up to approximately 3 years
The time from randomization to disease progression on the next-line of therapy, or death from any cause
Up to approximately 3 years
Incidence of adverse events (AEs)
Time Frame: Through 30 days after the last study treatment; approximately 1 year
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through 30 days after the last study treatment; approximately 1 year
Incidence of dose alterations
Time Frame: Through 30 days after the last study treatment; approximately 1 year
Through 30 days after the last study treatment; approximately 1 year
Trough concentration (Ctrough)
Time Frame: Approximately 4 months
PK parameter
Approximately 4 months
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
Time Frame: Up to approximately 3 years
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by BICR
Up to approximately 3 years
cORR per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The proportion of participants with confirmed CR or PR according to RECIST v1.1, as assessed by investigators
Up to approximately 3 years
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
Time Frame: Through 30-37 days after the last study treatment; approximately 1 year
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/quality of life (QoL) scales, higher scores indicate better functioning or global health status/quality of life (QoL). For symptom scales, higher scores indicate greater symptom burden.
Through 30-37 days after the last study treatment; approximately 1 year
Time to meaningful change in EORTC QLQ30 score
Time Frame: Through 30-37 days after the last study treatment; approximately 1 year

The time from baseline to the first onset of a ≥10-point changes in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100.

For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Through 30-37 days after the last study treatment; approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Jorge Ramos, DO, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNTUC-029
  • 2021-002672-40 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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