NCT04211337Active, not recruitingPhase 3
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
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)
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 291 (actual)
- First submitted
- 24 Dec 2019
- Start date
- 11 Feb 2020
- Primary completion date
- 22 May 2023
- Lead sponsor
- Loxo Oncology, Inc.
- Diseases
- Thyroid cancer, Childhood cancers
- NCT number
- NCT04211337
- EU CT number
- 2023-506782-56-00
- EudraCT number
- 2019-001978-28
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 291
- From 11 Feb 2020 to the primary completion date, 22 May 2023
- 123 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS or BRAF gene mutations and NTRK gene fusions.
- Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
Criteria the registry did not label
- At least 18 years of age (participants as young as 12 years of age will be allowed if permitted by local regulatory authorities).
- Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease.
- Radiographic progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at screening compared with a previous image taken within the prior 14 months as assessed by the BICR. Participants with measurable or non-measurable but evaluable disease are eligible; however, participants with non-measurable disease may not have disease limited to bone sites only.
- A defined/acceptable RET gene alteration identified in a tumor, germline deoxyribonucleic acid (DNA) or blood sample.
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (123)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Fundação Pio XII - Hospital de Câncer de Barretos Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Oncocentro Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Hospital de Cancer de Londrina Coordinator of this site? Confirm its status | Londrina | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital de Clínicas de Ribeirão Preto Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Grupo COI - Clínicas Oncológicas Integradas Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Grupo Oncoclínicas Botafogo Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto Nacional de Câncer - INCA Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Icesp - Instituto Do Câncer Do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Sirio Libanes Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Centro Paulista de Oncologia Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto D'Or de Pesquisa e Ensino (IDOR) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Beijing Tongren Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sun Yat-Sen University Cancer Centre Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Gansu Cancer Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Univerzita Karlova 2 Lekarska Fakulta Coordinator of this site? Confirm its status | Prague 5 | Czechia | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum - Essen Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Universitaetsklinikum Magdeburg AöR Coordinator of this site? Confirm its status | Magdeburg | Germany | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| München Campus Großhadern - Medizinische Klinik und Poliklinik IV Coordinator of this site? Confirm its status | München | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Assistance Publique Hôpitaux de Marseille - Hôpital Nord Coordinator of this site? Confirm its status | Bouches-du-Rhône | France | Completed |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Completed |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont Ferrand Cedex1 | France | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Hopital Claude Huriez - CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| University Hospitals Pitie Salpetriere - Charles Foix Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Paul Strauss Coordinator of this site? Confirm its status | STRASBOURG, Alsace | France | Completed |
| Institut Universitaire Du Cancer Toulouse-Oncopole Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Velindre Cancer Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Gartnavel General Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Marsden Hospital (Sutton) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Marsden Hospital (Chelsea) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Weston Park Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Post Graduate Institute of Medical Education & Research (PGIMER) Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| Apollo Gleneagles Hospitals Kolkata Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| HCG Manavata Cancer Centre Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| Deenanath Mangeshkar Hospital & Research Centre Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Grant Medical Foundation Ruby Hall Clinic Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Regional Cancer Centre - Thiruvananthapuram Coordinator of this site? Confirm its status | Thiruvananthapuram | India | Unknown status |
| Istituto Auxologico Italiano Coordinator of this site? Confirm its status | Milano | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| National Hospital Organization Kyushu Medical Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Japanese Foundation for Cancer Research Coordinator of this site? Confirm its status | Koto | Japan | Unknown status |
| Aichi Cancer Center Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Yokohama City University Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Jungbuk | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Completed |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Completed |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Active, not recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Active, not recruiting |
| Clinic Evimed Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| Endocrinology Research Center of Rosmedtechnologies Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological Coordinator of this site? Confirm its status | Obninsk | Russia | Unknown status |
| Saint Petersburg State University Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Saint-Petersburg city clinical oncology dispensary Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UCLA Hematology/Oncology - Westwood (Building 100) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Wisconsin Hospitals and Clinics Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of California Davis (UC Davis) Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.