Spots Global Cancer Trial Database for A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
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Trial Identification
Brief Title: A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Official Title: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)
Study ID: NCT04211337
Conditions
Study Description
Brief Summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
Detailed Description: Adaptive sample size re-estimation will be performed at interim analysis. The sample size could be increased from approximately 250 to 400 depending on the results of interim analysis.
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Mayo Clinic in Arizona - Phoenix, Phoenix, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
University of California San Diego, La Jolla, California, United States
UCLA Hematology/Oncology - Westwood (Building 100), Los Angeles, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center, Sacramento, California, United States
UCSF Medical Center at Mission Bay, San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Emory University, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic in Rochester, Minnesota, Rochester, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Providence Cancer Center Oncology Hematology Care, Portland, Oregon, United States
University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Wisconsin Hospitals and Clinics, Madison, Wisconsin, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
Antwerp University Hospital, Edegem, Antwerpen, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman, Liège, , Belgium
Oncocentro, Belo Horizonte, Minas Gerais, Brazil
Hospital de Cancer de Londrina, Londrina, Paraná, Brazil
Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, São Paulo, Brazil
Centro de Pesquisa Sao Lucas, Campinas, São Paulo, Brazil
Hospital de Clínicas de Ribeirão Preto, Ribeirão Preto, São Paulo, Brazil
Hospital Sírio Libanês, Sao Paulo, São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR), Sao Paulo, São Paulo, Brazil
Instituto Nacional de Câncer - INCA, Rio de Janeiro, , Brazil
Grupo Oncoclínicas Botafogo, Rio de Janeiro, , Brazil
Grupo COI - Clínicas Oncológicas Integradas, Rio de Janeiro, , Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo, São Paulo, , Brazil
Centro Paulista de Oncologia Clínica, São Paulo, , Brazil
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Anhui Provincial Hospital, Hefei, Anhui, China
Beijing Tongren Hospital affiliated to Capital Medical University, Beijing, Beijing, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
The First Affiliated Hospital Of Fujian Medical University, Fuzhou, Fujian, China
Gansu Cancer Hospital, Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Centre, Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
Jilin Cancer Hospital, Changchun, Jilin, China
Jinan Central Hospital, Jinan, Shandong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
West China Hospital, Sichuan University, Cheng Du, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Fakultní nemocnice Brno Bohunice, Brno, Brno-město, Czechia
Fakultni nemocnice Motol, Praha, Praha 5, Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Centre Paul Strauss, Strasbourg, Alsace, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, Aquitaine, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord, Marseille, Bouches-du-Rhône, France
Centre François Baclesse, Caen, Calvados, France
Centre Georges François Leclerc, Dijon, Côte-d'Or, France
Institut Claudius Regaud, Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire d'Angers, Angers, Maine-et-Loire, France
Hopital Claude Huriez - CHU de Lille, Lille, Nord, France
Pitie Salpetriere University Hospital, Paris, Orne, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne, Clermont-Ferrand, Puy-de-Dôme, France
Centre Leon Berard, Lyon, Rhône-Alpes, France
Gustave Roussy, Villejuif, Val-de-Marne, France
Klinikum der Universität München Großhadern, München, Bayern, Germany
Klinikum der Universität München Großhadern, Würzburg, Bayern, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Universitaetsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz, Mainz, Rheinland-Pfalz, Germany
Otto-von-Guericke-Universität Magdeburg, Magdeburg, Sachsen-Anhalt, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte, Berlin, , Germany
Hämato-Onkologie Hamburg, Prof. Laack und Partner, Hamburg, , Germany
Alexandra General Hospital of Athens, Athina, Attikí, Greece
University General Hospital of Heraklion, Heraklion, Irakleío, Greece
European Interbalkan Medical Center, Thessaloníki, Thessaloniki, Greece
Regional Cancer Centre - Thiruvananthapuram, Thiruvananthapuram, Kerala, India
HCG Manavata Cancer Centre, Nashik, Maharashtra, India
Grant Medical Foundation - Ruby Hall Clinic, Pune, Maharashtra, India
Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, India
Apollo Gleneagles Hospitals Kolkata, Kolkata, West Bengal, India
Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, , India
Rabin Medical Center, Petah-Tikva, HaMerkaz, Israel
Sheba Medical Center, Ramat Gan, HaMerkaz, Israel
Hadassah Medical Center, Jerusalem, Yerushalayim, Israel
University of Naples Federico II, Napoli, Campania, Italy
Policlinico Umberto I, Roma, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Lombardia, Italy
Istituto Auxologico Italiano, Milan, Milano, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy
Istituto Nazionale Tumori Regina Elena, Rome, Roma, Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, Toscana, Italy
Ospedale Le Scotte, Siena, Toscana, Italy
Istituto Oncologico Veneto IRCCS, Padova, Veneto, Italy
Azienda Ospedaliera Garibaldi, Catania, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kobe University Hospital, Kobe, Hyogo, Japan
Yokohama City University Hospital, Yokohama, Kanagawa, Japan
Osaka University Hospital, Suita, Osaka, Japan
Japanese Foundation for Cancer Research, Koto, Tokyo, Japan
National Hospital Organization Kyushu Medical Center, Fukuoka, , Japan
Chungbuk National University Hospital, Chungbuk, Chungcheongbuk-do [Chungbuk], Korea, Republic of
Asan Medical Center, Seoul, Korea, Korea, Republic of
National Cancer Center, Goyang-si, Kyǒnggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Maastricht UMC+, Maastricht, Limburg, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, Noord-Holland, Netherlands
Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Narodowy Instytut Onkologii - Oddzial w Gliwicach, Gliwice, Śląskie, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Kielce, Świętokrzyskie, Poland
Clinic Evimed, Chelyabinsk, Chelyabinskaya Oblast', Russian Federation
A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological, Obninsk, Kalužskaja Oblast', Russian Federation
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF, Moscow, Moskva, Russian Federation
Endocrinology Research Center of Rosmedtechnologies, Moscow, Moskva, Russian Federation
Saint Petersburg State University, Saint Petersburg, Sankt-Peterburg, Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary, Saint Petersburg, Sankt-Peterburg, Russian Federation
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals, L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Institut Català d'Oncologia (ICO) - Girona, Girona, Girona [Gerona], Spain
Clinica Universidad de Navarra, Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Ramón y Cajal, Madrid, Madrid, Comunidad De, Spain
Hospital Universitario 12 de Octubre, Madrid, Madrid, Comunidad De, Spain
Hospital Universitario La Paz, Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Virgen de la Victoria, Malaga, Málaga, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
China Medical University Hospital, Taichung, , Taiwan
National Cheng-Kung Uni. Hosp., Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Velindre Cancer Centre, Cardiff, Cardiff [Caerdydd Gb-crd], United Kingdom
Weston Park Hospital, Sheffield, England, United Kingdom
Gartnavel General Hospital, Glasgow, Glasgow City, United Kingdom
Royal Marsden Hospital (Chelsea), London, Kensington And Chelsea, United Kingdom
University College London Hospital, London, London, City Of, United Kingdom
Royal Marsden NHS Trust, Sutton, Surrey, United Kingdom
Royal Marsden Hospital (Sutton), London, Sutton, United Kingdom
Contact Details
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR
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