A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
NCT ID: NCT04211337
Last Updated: 2025-04-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
291 participants
INTERVENTIONAL
2020-02-11
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cabozantinib or Vandetanib - Treatment B (TRT B)
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
Cabozantinib
Administered orally
Vandetanib
Administered orally
Selpercatinib - Treatment A (TRT A)
160 milligrams Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
Selpercatinib
Administered orally
Interventions
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Selpercatinib
Administered orally
Cabozantinib
Administered orally
Vandetanib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor tissue in sufficient quantity to allow for retrospective central analysis of RET mutation status
* Eastern Cooperative Oncology Group performance status score of 0 to 2.
* Adequate hematologic, hepatic, and renal function and electrolytes.
* Men and women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 4 months following the last dose of study drug.
* Ability to swallow capsules.
Exclusion Criteria
* Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
* Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months, history of Torsades de pointes, or prolongation of the QTcF \>470 milliseconds on more than one electrocardiogram (ECG) during screening. Participants who are intended to receive vandetanib if randomized to the control arm are ineligible if QTcF is \>450 milliseconds.
* Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing uncontrolled intercurrent illness.
* Active hemorrhage or at significant risk for hemorrhage.
* Other malignancy unless nonmelanoma skin cancer, carcinoma in situ or malignancy diagnosed ≥2 years previously and not currently active. Participants with multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be eligible.
12 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Loxo Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Napoli, 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
Padua, 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
Countries
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References
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Hadoux J, Elisei R, Brose MS, Hoff AO, Robinson BG, Gao M, Jarzab B, Isaev P, Kopeckova K, Wadsley J, Fuhrer D, Keam B, Bardet S, Sherman EJ, Tahara M, Hu MI, Singh R, Lin Y, Soldatenkova V, Wright J, Lin B, Maeda P, Capdevila J, Wirth LJ; LIBRETTO-531 Trial Investigators. Phase 3 Trial of Selpercatinib in Advanced RET-Mutant Medullary Thyroid Cancer. N Engl J Med. 2023 Nov 16;389(20):1851-1861. doi: 10.1056/NEJMoa2309719. Epub 2023 Oct 21.
Wirth LJ, Brose MS, Elisei R, Capdevila J, Hoff AO, Hu MI, Tahara M, Robinson B, Gao M, Xia M, Maeda P, Sherman E. LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-naive RET-mutant medullary thyroid cancer. Future Oncol. 2022 Sep;18(28):3143-3150. doi: 10.2217/fon-2022-0657. Epub 2022 Aug 15.
Jaber T, Dadu R, Hu MI. Medullary thyroid carcinoma. Curr Opin Endocrinol Diabetes Obes. 2021 Oct 1;28(5):540-546. doi: 10.1097/MED.0000000000000662.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Other Identifiers
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J2G-MC-JZJB
Identifier Type: OTHER
Identifier Source: secondary_id
2019-001978-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17478
Identifier Type: -
Identifier Source: org_study_id
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