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New drug shows promise for Hard-to-Treat thyroid cancer

NCT ID NCT04211337

Disease control Sponsor: Loxo Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug selpercatinib works better than current standard treatments for people with a specific type of advanced thyroid cancer (medullary thyroid cancer with a RET gene mutation). About 291 adults (and some teens) whose cancer has spread or can't be removed by surgery are taking part. The main goal is to see if selpercatinib delays cancer growth longer than the usual drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

291 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

Carcinoma, Medullary medullary thyroid gland carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Medullary thyroid cancer

Contacts and locations

Locations

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

    Obninsk, Kalužskaja Oblast', 249036, Russia

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Alexandra Hospital

    Athens, Attikí, 115 28, Greece

  • Anhui Provincial Hospital

    Hefei, Anhui, 230071, China

  • Apollo Gleneagles Hospitals Kolkata

    Kolkata, West Bengal, 700054, India

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord

    Marseille, Bouches-du-Rhône, 13915, France

  • Azienda Ospedaliera Garibaldi

    Catania, 95124, Italy

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Tuscany, 56124, Italy

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

    Turin, Piedmont, 10126, Italy

  • Beijing Tongren Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100730, China

  • Centre François Baclesse

    Caen, Calvados, 14076, France

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079, France

  • Centre Hospitalier Universitaire d'Angers

    Angers, Maine-et-Loire, 49933, France

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000, Belgium

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

    Clermont-Ferrand, Puy-de-Dôme, 63011, France

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Centre Paul Strauss

    Strasbourg, Alsace, 67065, France

  • Centro Paulista de Oncologia Clínica

    São Paulo, 01452-000, Brazil

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo, 13060-904, Brazil

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117, Germany

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Chungbuk National University Hospital

    Taebuk, Chungcheongbuk-do [Chungbuk], 28644, South Korea

  • City of Hope National Medical Center

    Duarte, California, 91010-0269, United States

  • Clinic Evimed

    Chelyabinsk, Chelyabinsk Oblast, 454048, Russia

  • Clinica Universidad de Navarra

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004, India

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Endocrinology Research Center of Rosmedtechnologies

    Moscow, Moscow, 117292, Russia

  • European Interbalkan Medical Center

    Thessaloniki, Thessaloniki, 570 01, Greece

  • Fakultni nemocnice Motol

    Prague, Praha 5, 150 06, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-město, 625 00, Czechia

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

    Moscow, Moscow, 115478, Russia

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032, China

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784400, Brazil

  • Gansu Cancer Hospital

    Lanzhou, Gansu, 730050, China

  • Gartnavel General Hospital

    Glasgow, Glasgow City, g12OYN, United Kingdom

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, Maharashtra, 411001, India

  • Grupo COI - Clínicas Oncológicas Integradas

    Rio de Janeiro, 22775-001, Brazil

  • Grupo Oncoclínicas Botafogo

    Rio de Janeiro, 22250-905, Brazil

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94800, France

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422001, India

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001, Israel

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord, 59037, France

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009, Spain

  • Hospital Sírio Libanês

    São Paulo, São Paulo, 01308-060, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 8035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010, Spain

  • Hospital de Cancer de Londrina

    Londrina, Paraná, 86015-520, Brazil

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Hämato-Onkologie Hamburg, Prof. Laack und Partner

    Hamburg, 20251, Germany

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000, Brazil

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine, 33076, France

  • Institut Català d'Oncologia (ICO) - Girona

    Girona, Girona [Gerona], 17007, Spain

  • Institut Claudius Regaud

    Toulouse, Haute-Garonne, 31059, France

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 8907, Spain

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    São Paulo, São Paulo, 04543-000, Brazil

  • Instituto Nacional de Câncer - INCA

    Rio de Janeiro, 20230-130, Brazil

  • Istituto Auxologico Italiano

    Milan, Milano, 20122, Italy

  • Istituto Nazionale Tumori Regina Elena

    Rome, Roma, 00144, Italy

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128, Italy

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550, Japan

  • Jilin Cancer Hospital

    Changchun, Jilin, 132000, China

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Klinikum der Universität München Großhadern

    München, Bavaria, 81337, Germany

  • Klinikum der Universität München Großhadern

    Würzburg, Bavaria, 97080, Germany

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017, Japan

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA, Netherlands

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Maastricht UMC+

    Maastricht, Limburg, 6229 HX, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10017, United States

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000, China

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach

    Gliwice, Silesian Voivodeship, 44-101, Poland

  • National Cancer Center

    Goyang-si, Kyǒnggi-do, 10408, South Korea

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563, Japan

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

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Oncocentro

    Belo Horizonte, Minas Gerais, 30380-680, Brazil

  • Osaka University Hospital

    Suita, Osaka, 565-0871, Japan

  • Ospedale Le Scotte

    Siena, Tuscany, 53100, Italy

  • Otto-von-Guericke-Universität Magdeburg

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3050, Australia

  • Pitie Salpetriere University Hospital

    Paris, Orne, 75013, France

  • Policlinico Umberto I

    Rome, Lazio, 00161, Italy

  • Post Graduate Institute of Medical Education & Research (PGIMER)

    Chandigarh, 160012, India

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492, Israel

  • Regional Cancer Centre - Thiruvananthapuram

    Thiruvananthapuram, Kerala, 695011, India

  • Royal Marsden Hospital (Chelsea)

    London, Kensington and Chelsea, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital (Sutton)

    London, Sutton, SM2 5PT, United Kingdom

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Saint Petersburg State University

    Saint Petersburg, Sankt-Peterburg, 190020, Russia

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, Sankt-Peterburg, 198255, Russia

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 6351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 3080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 3722, South Korea

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601, Israel

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009, Australia

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016, China

  • Sun Yat-Sen University Cancer Centre

    Guangzhou, Guangdong, 510060, China

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, Fujian, 350005, China

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19114, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • UCLA Hematology/Oncology - Westwood (Building 100)

    Los Angeles, California, 90095, United States

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45122, Germany

  • University College London Hospital

    London, London, City of, NW1 2PG, United Kingdom

  • University General Hospital of Heraklion

    Heraklion, Irakleío, 711 10, Greece

  • University Medical Center Groningen

    Groningen, 9713 GR, Netherlands

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Naples Federico II

    Naples, Campania, 80131, Italy

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin, 53792, United States

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Velindre Cancer Centre

    Cardiff, Cardiff [Caerdydd Gb-crd], CF14 2TL, United Kingdom

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Weston Park Hospital

    Sheffield, England, S10 2SJ, United Kingdom

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014, China

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