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ACTIVE NOT RECRUITING
NCT04211337
PHASE3

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

Sponsor: Loxo Oncology, Inc.

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

291

Start Date

2020-02-11

Completion Date

2027-11

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Selpercatinib

Administered orally

DRUG

Cabozantinib

Administered orally

DRUG

Vandetanib

Administered orally

Locations (143)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, 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

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 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

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

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, United States

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

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

São Paulo, São Paulo, Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR)

São 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 Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 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 Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 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

Prague, 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

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, 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

Gustave Roussy

Villejuif, Val-de-Marne, France

Klinikum der Universität München Großhadern

München, Bavaria, Germany

Klinikum der Universität München Großhadern

Würzburg, Bavaria, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, Germany

Hämato-Onkologie Hamburg, Prof. Laack und Partner

Hamburg, Germany

Alexandra Hospital

Athens, Attikí, Greece

University General Hospital of Heraklion

Heraklion, Irakleío, Greece

European Interbalkan Medical Center

Thessaloniki, 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, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

University of Naples Federico II

Naples, Campania, Italy

Policlinico Umberto I

Rome, Lazio, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Istituto Auxologico Italiano

Milan, Milano, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Istituto Nazionale Tumori Regina Elena

Rome, Roma, Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, Tuscany, Italy

Ospedale Le Scotte

Siena, Tuscany, Italy

Istituto Oncologico Veneto IRCCS

Padova, Veneto, Italy

Azienda Ospedaliera Garibaldi

Catania, Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kobe University Hospital

Kobe, Hyōgo, 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

Maastricht UMC+

Maastricht, Limburg, Netherlands

Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)

Amsterdam, North Holland, Netherlands

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Narodowy Instytut Onkologii - Oddzial w Gliwicach

Gliwice, Silesian Voivodeship, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Kielce, Świętokrzyskie Voivodeship, Poland

Clinic Evimed

Chelyabinsk, Chelyabinsk Oblast, Russia

A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological

Obninsk, Kalužskaja Oblast', Russia

Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

Moscow, Moscow, Russia

Endocrinology Research Center of Rosmedtechnologies

Moscow, Moscow, Russia

Saint Petersburg State University

Saint Petersburg, Sankt-Peterburg, Russia

Saint-Petersburg City Clinical Oncology Dispensary

Saint Petersburg, Sankt-Peterburg, Russia

Chungbuk National University Hospital

Jungbuk, Chungcheongbuk-do [Chungbuk], South Korea

National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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

Málaga, Málaga, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

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 Hospital (Sutton)

London, Sutton, United Kingdom