Get Involved
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Study Purpose
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.
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 12 Years and Over |
| Gender | All |
- - 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.
- - 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.
- - 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.
- - 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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04211337 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Loxo Oncology, Inc. |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Medullary Thyroid Cancer |
| Study Website: | View Trial Website |
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.
Arms
Experimental: 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).
Active Comparator: 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
Interventions
Drug: - Selpercatinib
Administered orally
Drug: - Cabozantinib
Administered orally
Drug: - Vandetanib
Administered orally
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764, 35249
Status
Address
City of Hope National Medical Center
Duarte 5344147, California 5332921, 91010-0269
Status
Address
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles 5368361, California 5332921, 90095
Status
Address
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento 5389489, California 5332921, 95817
Status
Address
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance 5403022, California 5332921, 90502
Status
Address
Emory University
Atlanta 4180439, Georgia 4197000, 30322
Status
Address
University of Chicago Medical Center
Chicago 4887398, Illinois 4896861, 60637
Status
Address
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926, 02114
Status
Address
University of Michigan
Ann Arbor 4984247, Michigan 5001836, 48109
Status
Address
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, 10017
Status
Address
University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418, 45219
Status
Address
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418, 43210
Status
Address
University of Pennsylvania Hospital
Philadelphia 4560349, Pennsylvania 6254927, 19104
Status
Address
Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927, 19114
Status
Address
University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286, 77030
Status
Address
University of Wisconsin Hospitals and Clinics
Madison 5261457, Wisconsin 5279468, 53792
International Sites
Status
Address
Royal North Shore Hospital
St Leonards 8029783, New South Wales 2155400, 2065
Status
Address
The Alfred Hospital
Melbourne 2158177, Victoria 2145234, 3004
Status
Address
Peter MacCallum Cancer Centre
Melbourne 2158177, Victoria 2145234, 3050
Status
Address
Sir Charles Gairdner Hospital
Perth 2063523, Western Australia 2058645, 6009
Status
Address
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège 2792413, , 4000
Status
Address
Oncocentro
Belo Horizonte 3470127, Minas Gerais 3457153, 30380-680
Status
Address
Hospital de Cancer de Londrina
Londrina 3458449, Paraná 3455077, 86015-520
Status
Address
Hospital de Clinicas de Porto Alegre
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90035-903
Status
Address
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos 3470451, São Paulo 3448433, 14784400
Status
Address
Centro de Pesquisa Sao Lucas
Campinas 3467865, São Paulo 3448433, 13060-904
Status
Address
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto 3451328, São Paulo 3448433, 14051-140
Status
Address
Hospital Sírio Libanês
São Paulo 3448439, São Paulo 3448433, 01308-060
Status
Address
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo 3448439, São Paulo 3448433, 04543-000
Status
Address
Instituto Nacional de Câncer - INCA
Rio de Janeiro 3451190, , 20230-130
Status
Address
Grupo Oncoclínicas Botafogo
Rio de Janeiro 3451190, , 22250-905
Status
Address
Grupo COI - Clínicas Oncológicas Integradas
Rio de Janeiro 3451190, , 22775-001
Status
Address
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo 3448439, , 01246-000
Status
Address
Centro Paulista de Oncologia Clínica
São Paulo 3448439, , 01452-000
Status
Address
Princess Margaret Cancer Centre
Toronto 6167865, Ontario 6093943, M5G 2M9
Status
Address
Anhui Provincial Hospital
Hefei 1808722, Anhui 1818058, 230071
Status
Address
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing 1816670, Beijing Municipality 2038349, 100730
Status
Address
Chongqing University Cancer Hospital
Chongqing 1814906, Chongqing Municipality 1814905, 400030
Status
Address
The First Affiliated Hospital Of Fujian Medical University
Fuzhou 1810821, Fujian 1811017, 350005
Status
Address
Gansu Cancer Hospital
Lanzhou 1804430, Gansu 1810676, 730050
Status
Address
Sun Yat-Sen University Cancer Centre
Guangzhou 1809858, Guangdong 1809935, 510060
Status
Address
Harbin Medical University Cancer Hospital
Harbin 2037013, Heilongjiang 2036965, 150081
Status
Address
Henan Cancer Hospital
Zhengzhou 1784658, Henan 1808520, 450008
Status
Address
Hunan Cancer Hospital
Changsha 1815577, Hunan 1806691, 410013
Status
Address
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing 1799962, Jiangsu 1806260, 210000
Status
Address
Jilin Cancer Hospital
Changchun 2038180, Jilin 2036500, 132000
Status
Address
Jinan Central Hospital
Jinan 1805753, Shandong 1796328, 250013
Status
Address
Fudan University Shanghai Cancer Center
Shanghai 1796236, Shanghai Municipality 1796231, 200032
Status
Address
West China Hospital, Sichuan University
Chengdu 1815286, Sichuan 1794299, 610041
Status
Address
Tianjin Medical University Cancer Institute and Hospital
Tianjin 1792947, Tianjin Municipality 1792943, 300060
Status
Address
First Affiliated Hospital of Kunming Medical University
Kunming 1804651, Yunnan 1785694, 650032
Status
Address
Zhejiang Provincial People's Hospital
Hangzhou 1808926, Zhejiang 1784764, 310014
Status
Address
Sir Run Run Shaw Hospital
Hangzhou 1808926, Zhejiang 1784764, 310016
Status
Address
Zhejiang Cancer Hospital
Hangzhou 1808926, Zhejiang 1784764, 310022
Status
Address
Fakultní nemocnice Brno Bohunice
Brno 3078610, Brno-město, 625 00
Status
Address
Fakultni nemocnice Motol
Prague 3067696, Praha 5, 150 06
Status
Address
Fakultni nemocnice Olomouc
Olomouc 3069011, , 779 00
Status
Address
Centre Paul Strauss
Strasbourg 2973783, Alsace, 67065
Status
Address
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux 3031582, Aquitaine, 33076
Status
Address
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille 2995469, Bouches-du-Rhône, 13915
Status
Address
Centre François Baclesse
Caen 3029241, Calvados, 14076
Status
Address
Centre Georges François Leclerc
Dijon 3021372, Côte-d'Or, 21079
Status
Address
Institut Claudius Regaud
Toulouse 2972315, Haute-Garonne, 31059
Status
Address
Centre Hospitalier Universitaire d'Angers
Angers 3037656, Maine-et-Loire, 49933
Status
Address
Hopital Claude Huriez - CHU de Lille
Lille 2998324, Nord, 59037
Status
Address
Pitie Salpetriere University Hospital
Paris 2988507, Orne, 75013
Status
Address
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand 3024635, Puy-de-Dôme, 63011
Status
Address
Centre Leon Berard
Lyon 2996944, Rhône-Alpes, 69008
Status
Address
Gustave Roussy
Villejuif 2968705, Val-de-Marne, 94800
Status
Address
Klinikum der Universität München Großhadern
München 2867713, Bavaria 2951839, 81337
Status
Address
Klinikum der Universität München Großhadern
Würzburg 2805615, Bavaria 2951839, 97080
Status
Address
Medizinische Hochschule Hannover
Hanover 2910831, Lower Saxony 2862926, 30625
Status
Address
Universitaetsklinikum Essen
Essen 2928810, North Rhine-Westphalia 2861876, 45122
Status
Address
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz 2874225, Rhineland-Palatinate 2847618, 55131
Status
Address
Otto-von-Guericke-Universität Magdeburg
Magdeburg 2874545, Saxony-Anhalt 2842565, 39120
Status
Address
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin 2950159, , 10117
Status
Address
Hämato-Onkologie Hamburg, Prof. Laack und Partner
Hamburg 2911298, , 20251
Status
Address
Alexandra Hospital
Athens 264371, Attikí, 115 28
Status
Address
University General Hospital of Heraklion
Heraklion 261745, Irakleío, 711 10
Status
Address
European Interbalkan Medical Center
Thessaloniki 734077, Thessaloniki, 570 01
Status
Address
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram 1254163, Kerala 1267254, 695011
Status
Address
HCG Manavata Cancer Centre
Nashik 1261731, Maharashtra 1264418, 422001
Status
Address
Grant Medical Foundation - Ruby Hall Clinic
Pune 1259229, Maharashtra 1264418, 411001
Status
Address
Deenanath Mangeshkar Hospital & Research Centre
Pune 1259229, Maharashtra 1264418, 411004
Status
Address
Apollo Gleneagles Hospitals Kolkata
Kolkata 1275004, West Bengal 1252881, 700054
Status
Address
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh 1274746, , 160012
Status
Address
Rabin Medical Center
Petah Tikva 293918, Central District 294904, 4941492
Status
Address
Sheba Medical Center
Ramat Gan, Central District 294904, 5265601
Status
Address
Hadassah Medical Center
Jerusalem 281184, Jerusalem 293198, 9112001
Status
Address
University of Naples Federico II
Napoli 9031661, Campania 3181042, 80131
Status
Address
Policlinico Umberto I
Rome 3169070, Lazio 3174976, 00161
Status
Address
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan 3173435, Lombardy 3174618, 20133
Status
Address
Istituto Auxologico Italiano
Milan 3173435, Milano, 20122
Status
Address
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin 3165524, Piedmont 3170831, 10126
Status
Address
Istituto Nazionale Tumori Regina Elena
Rome 3169070, Roma, 00144
Status
Address
Azienda Ospedaliera Universitaria Pisana
Pisa 3170647, Tuscany 3165361, 56124
Status
Address
Ospedale Le Scotte
Siena 3166548, Tuscany 3165361, 53100
Status
Address
Istituto Oncologico Veneto IRCCS
Padua 3171728, Veneto 3164604, 35128
Status
Address
Azienda Ospedaliera Garibaldi
Catania 2525068, , 95124
Status
Address
Aichi Cancer Center Hospital
Nagoya 1856057, Aichi-ken 1865694, 464-8681
Status
Address
National Cancer Center Hospital East
Kashiwa 1859924, Chiba 2113014, 277-8577
Status
Address
Hokkaido University Hospital
Sapporo 2128295, Hokkaido 2130037, 060-8648
Status
Address
Kobe University Hospital
Kobe 1859171, Hyōgo 1862047, 650-0017
Status
Address
Yokohama City University Hospital
Yokohama 1848354, Kanagawa 1860291, 236-0004
Status
Address
Osaka University Hospital
Suita 1851483, Osaka 1853904, 565-0871
Status
Address
Japanese Foundation for Cancer Research
Koto, Tokyo 1850144, 135-8550
Status
Address
National Hospital Organization Kyushu Medical Center
Fukuoka 1863967, , 810-8563
Status
Address
Maastricht UMC+
Maastricht 2751283, Limburg 2751596, 6229 HX
Status
Address
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam 2759794, North Holland 2749879, 1066 CX
Status
Address
Leids Universitair Medisch Centrum
Leiden 2751773, South Holland 2743698, 2333 ZA
Status
Address
University Medical Center Groningen
Groningen 2755251, , 9713 GR
Status
Address
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice 3099230, Silesian Voivodeship 3337497, 44-101
Status
Address
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Kielce 769250, Świętokrzyskie Voivodeship 858790, 25-734
Status
Address
Clinic Evimed
Chelyabinsk 1508291, Chelyabinsk Oblast 1508290, 454048
Status
Address
A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
Obninsk 516436, Kalužskaja Oblast', 249036
Status
Address
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
Moscow 524901, Moscow 524894, 115478
Status
Address
Endocrinology Research Center of Rosmedtechnologies
Moscow 524901, Moscow 524894, 117292
Status
Address
Saint Petersburg State University
Saint Petersburg 498817, Sankt-Peterburg 536203, 190020
Status
Address
Saint-Petersburg City Clinical Oncology Dispensary
Saint Petersburg 498817, Sankt-Peterburg 536203, 198255
Status
Address
Chungbuk National University Hospital
Jungbuk 6876679, Chungcheongbuk-do [Chungbuk], 28644
Status
Address
National Cancer Center
Goyang-si 1842485, Kyǒnggi-do, 10408
Status
Address
Seoul National University Bundang Hospital
Seongnam 6876792, Kyǒnggi-do, 13620
Status
Address
Seoul National University Hospital
Seoul 1835848, Seoul-teukbyeolsi [Seoul], 3080
Status
Address
Severance Hospital, Yonsei University Health System
Seoul 1835848, Seoul-teukbyeolsi [Seoul], 3722
Status
Address
Samsung Medical Center
Seoul 1835848, Seoul-teukbyeolsi [Seoul], 6351
Status
Address
Hospital Universitari Vall d'Hebron
Barcelona 3128760, Barcelona [Barcelona], 8035
Status
Address
Instituto Catalan de Oncologia - Hospital Duran i Reynals
L'Hospitalet de Llobregat 3120619, Catalunya [Cataluña], 8907
Status
Address
Institut Català d'Oncologia (ICO) - Girona
Girona 3121456, Girona [Gerona], 17007
Status
Address
Clinica Universidad de Navarra
Madrid 3117735, Madrid, Comunidad de, 28027
Status
Address
Hospital Universitario Ramón y Cajal
Madrid 3117735, Madrid, Comunidad de, 28034
Status
Address
Hospital Universitario 12 de Octubre
Madrid 3117735, Madrid, Comunidad de, 28041
Status
Address
Hospital Universitario La Paz
Madrid 3117735, Madrid, Comunidad de, 28046
Status
Address
Hospital Universitario Virgen de la Victoria
Málaga 2514256, Málaga, 29010
Status
Address
Clinica Universidad de Navarra
Pamplona 3114472, Navarre 3115609, 31008
Status
Address
Hospital General Universitario Gregorio Marañon
Madrid 3117735, , 28009
Status
Address
Hospital Clinico San Carlos
Madrid 3117735, , 28040
Status
Address
Hospital Universitario Miguel Servet
Zaragoza 3104324, , 50009
Status
Address
Velindre Cancer Centre
Cardiff 2653822, Cardiff [Caerdydd Gb-crd], CF14 2TL
Status
Address
Weston Park Hospital
Sheffield 2638077, England 6269131, S10 2SJ
Status
Address
Gartnavel General Hospital
Glasgow 2648579, Glasgow City, g12OYN
Status
Address
Royal Marsden Hospital (Chelsea)
London 2643743, Kensington and Chelsea, SW3 6JJ
Status
Address
University College London Hospital
London 2643743, London, City of, NW1 2PG
Status
Address
Royal Marsden Hospital (Sutton)
London 2643743, Sutton, SM2 5PT
