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

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

NCT ID: NCT04211337

Condition: Medullary Thyroid Cancer

Conditions: Official terms:
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases

Conditions: Keywords:
medullary thyroid carcinoma
targeted therapy

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Selpercatinib
Description: Administered orally
Arm group label: Selpercatinib - Treatment A (TRT A)

Other name: LY3527723

Other name: LOXO-292

Intervention type: Drug
Intervention name: Cabozantinib
Description: Administered orally
Arm group label: Cabozantinib or Vandetanib - Treatment B (TRT B)

Intervention type: Drug
Intervention name: Vandetanib
Description: Administered orally
Arm group label: Cabozantinib or Vandetanib - Treatment B (TRT B)

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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
- 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.

Gender: All

Minimum age: 12 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama at Birmingham

Address:
City: Birmingham
Zip: 35249
Country: United States

Facility:
Name: City of Hope National Medical Center

Address:
City: Duarte
Zip: 91010-0269
Country: United States

Facility:
Name: UCLA Hematology/Oncology - Westwood (Building 100)

Address:
City: Los Angeles
Zip: 90095
Country: United States

Facility:
Name: University of California Davis (UC Davis) Comprehensive Cancer Center

Address:
City: Sacramento
Zip: 95817
Country: United States

Facility:
Name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Address:
City: Torrance
Zip: 90502
Country: United States

Facility:
Name: Emory University

Address:
City: Atlanta
Zip: 30322
Country: United States

Facility:
Name: University of Chicago Medical Center

Address:
City: Chicago
Zip: 60637
Country: United States

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: University of Michigan

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center

Address:
City: New York
Zip: 10017
Country: United States

Facility:
Name: University of Cincinnati Medical Center

Address:
City: Cincinnati
Zip: 45219
Country: United States

Facility:
Name: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Address:
City: Columbus
Zip: 43210
Country: United States

Facility:
Name: University of Pennsylvania Hospital

Address:
City: Philadelphia
Zip: 19104
Country: United States

Facility:
Name: Thomas Jefferson University

Address:
City: Philadelphia
Zip: 19114
Country: United States

Facility:
Name: University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: University of Wisconsin Hospitals and Clinics

Address:
City: Madison
Zip: 53792
Country: United States

Facility:
Name: Royal North Shore Hospital

Address:
City: St Leonards
Zip: 2065
Country: Australia

Facility:
Name: The Alfred Hospital

Address:
City: Melbourne
Zip: 3004
Country: Australia

Facility:
Name: Peter MacCallum Cancer Centre

Address:
City: Melbourne
Zip: 3050
Country: Australia

Facility:
Name: Sir Charles Gairdner Hospital

Address:
City: Perth
Zip: 6009
Country: Australia

Facility:
Name: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Address:
City: Liège
Zip: 4000
Country: Belgium

Facility:
Name: Oncocentro

Address:
City: Belo Horizonte
Zip: 30380-680
Country: Brazil

Facility:
Name: Hospital de Cancer de Londrina

Address:
City: Londrina
Zip: 86015-520
Country: Brazil

Facility:
Name: Hospital de Clinicas de Porto Alegre

Address:
City: Porto Alegre
Zip: 90035-903
Country: Brazil

Facility:
Name: Fundação Pio XII - Hospital de Câncer de Barretos

Address:
City: Barretos
Zip: 14784400
Country: Brazil

Facility:
Name: Centro de Pesquisa Sao Lucas

Address:
City: Campinas
Zip: 13060-904
Country: Brazil

Facility:
Name: Hospital de Clínicas de Ribeirão Preto

Address:
City: Ribeirão Preto
Zip: 14051-140
Country: Brazil

Facility:
Name: Hospital Sírio Libanês

Address:
City: Sao Paulo
Zip: 01308-060
Country: Brazil

Facility:
Name: Instituto D'Or de Pesquisa e Ensino (IDOR)

Address:
City: Sao Paulo
Zip: 04543-000
Country: Brazil

Facility:
Name: Instituto Nacional de Câncer - INCA

Address:
City: Rio de Janeiro
Zip: 20230-130
Country: Brazil

Facility:
Name: Grupo Oncoclínicas Botafogo

Address:
City: Rio de Janeiro
Zip: 22250-905
Country: Brazil

Facility:
Name: Grupo COI - Clínicas Oncológicas Integradas

Address:
City: Rio de Janeiro
Zip: 22775-001
Country: Brazil

Facility:
Name: Icesp - Instituto Do Câncer Do Estado de São Paulo

Address:
City: São Paulo
Zip: 01246-000
Country: Brazil

Facility:
Name: Centro Paulista de Oncologia Clínica

Address:
City: São Paulo
Zip: 01452-000
Country: Brazil

Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: Anhui Provincial Hospital

Address:
City: Hefei
Zip: 230071
Country: China

Facility:
Name: Beijing Tongren Hospital affiliated to Capital Medical University

Address:
City: Beijing
Zip: 100730
Country: China

Facility:
Name: Chongqing University Cancer Hospital

Address:
City: Chongqing
Zip: 400030
Country: China

Facility:
Name: The First Affiliated Hospital Of Fujian Medical University

Address:
City: Fuzhou
Zip: 350005
Country: China

Facility:
Name: Gansu Cancer Hospital

Address:
City: Lanzhou
Zip: 730050
Country: China

Facility:
Name: Sun Yat-Sen University Cancer Centre

Address:
City: Guangzhou
Zip: 510060
Country: China

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Harbin
Zip: 150081
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Hunan Cancer Hospital

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Address:
City: Nanjing
Zip: 210000
Country: China

Facility:
Name: Jilin Cancer Hospital

Address:
City: Changchun
Zip: 132000
Country: China

Facility:
Name: Jinan Central Hospital

Address:
City: Jinan
Zip: 250013
Country: China

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Facility:
Name: West China Hospital, Sichuan University

Address:
City: Cheng Du
Zip: 610041
Country: China

Facility:
Name: Tianjin Medical University Cancer Institute and Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Facility:
Name: First Affiliated Hospital of Kunming Medical University

Address:
City: Kunming
Zip: 650032
Country: China

Facility:
Name: Zhejiang Provincial People's Hospital

Address:
City: Hangzhou
Zip: 310014
Country: China

Facility:
Name: Sir Run Run Shaw Hospital

Address:
City: Hangzhou
Zip: 310016
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Zip: 310022
Country: China

Facility:
Name: Fakultní nemocnice Brno Bohunice

Address:
City: Brno
Zip: 625 00
Country: Czechia

Facility:
Name: Fakultni nemocnice Motol

Address:
City: Praha
Zip: 150 06
Country: Czechia

Facility:
Name: Fakultni nemocnice Olomouc

Address:
City: Olomouc
Zip: 779 00
Country: Czechia

Facility:
Name: Centre Paul Strauss

Address:
City: Strasbourg
Zip: 67065
Country: France

Facility:
Name: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Address:
City: Bordeaux
Zip: 33076
Country: France

Facility:
Name: Assistance Publique Hôpitaux de Marseille - Hôpital Nord

Address:
City: Marseille
Zip: 13915
Country: France

Facility:
Name: Centre François Baclesse

Address:
City: Caen
Zip: 14076
Country: France

Facility:
Name: Centre Georges François Leclerc

Address:
City: Dijon
Zip: 21079
Country: France

Facility:
Name: Institut Claudius Regaud

Address:
City: Toulouse
Zip: 31059
Country: France

Facility:
Name: Centre Hospitalier Universitaire d'Angers

Address:
City: Angers
Zip: 49933
Country: France

Facility:
Name: Hopital Claude Huriez - CHU de Lille

Address:
City: Lille
Zip: 59037
Country: France

Facility:
Name: Pitie Salpetriere University Hospital

Address:
City: Paris
Zip: 75013
Country: France

Facility:
Name: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

Address:
City: Clermont-Ferrand
Zip: 63011
Country: France

Facility:
Name: Centre Leon Berard

Address:
City: Lyon
Zip: 69008
Country: France

Facility:
Name: Gustave Roussy

Address:
City: Villejuif
Zip: 94800
Country: France

Facility:
Name: Klinikum der Universität München Großhadern

Address:
City: München
Zip: 81337
Country: Germany

Facility:
Name: Klinikum der Universität München Großhadern

Address:
City: Würzburg
Zip: 97080
Country: Germany

Facility:
Name: Medizinische Hochschule Hannover

Address:
City: Hannover
Zip: 30625
Country: Germany

Facility:
Name: Universitaetsklinikum Essen

Address:
City: Essen
Zip: 45122
Country: Germany

Facility:
Name: Universitätsmedizin Johannes Gutenberg Universität Mainz

Address:
City: Mainz
Zip: 55131
Country: Germany

Facility:
Name: Otto-von-Guericke-Universität Magdeburg

Address:
City: Magdeburg
Zip: 39120
Country: Germany

Facility:
Name: Charité Universitaetsmedizin Berlin - Campus Mitte

Address:
City: Berlin
Zip: 10117
Country: Germany

Facility:
Name: Hämato-Onkologie Hamburg, Prof. Laack und Partner

Address:
City: Hamburg
Zip: 20251
Country: Germany

Facility:
Name: Alexandra Hospital

Address:
City: Athina
Zip: 115 28
Country: Greece

Facility:
Name: University General Hospital of Heraklion

Address:
City: Heraklion
Zip: 711 10
Country: Greece

Facility:
Name: European Interbalkan Medical Center

Address:
City: Thessaloníki
Zip: 570 01
Country: Greece

Facility:
Name: Regional Cancer Centre - Thiruvananthapuram

Address:
City: Thiruvananthapuram
Zip: 695011
Country: India

Facility:
Name: HCG Manavata Cancer Centre

Address:
City: Nashik
Zip: 422001
Country: India

Facility:
Name: Grant Medical Foundation - Ruby Hall Clinic

Address:
City: Pune
Zip: 411001
Country: India

Facility:
Name: Deenanath Mangeshkar Hospital & Research Centre

Address:
City: Pune
Zip: 411004
Country: India

Facility:
Name: Apollo Gleneagles Hospitals Kolkata

Address:
City: Kolkata
Zip: 700054
Country: India

Facility:
Name: Post Graduate Institute of Medical Education & Research (PGIMER)

Address:
City: Chandigarh
Zip: 160012
Country: India

Facility:
Name: Rabin Medical Center

Address:
City: Petah-Tikva
Zip: 4941492
Country: Israel

Facility:
Name: Sheba Medical Center

Address:
City: Ramat Gan
Zip: 5265601
Country: Israel

Facility:
Name: Hadassah Medical Center

Address:
City: Jerusalem
Zip: 9112001
Country: Israel

Facility:
Name: University of Naples Federico II

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: Policlinico Umberto I

Address:
City: Roma
Zip: 00161
Country: Italy

Facility:
Name: Fondazione IRCCS Istituto Nazionale dei Tumori

Address:
City: Milan
Zip: 20133
Country: Italy

Facility:
Name: Istituto Auxologico Italiano

Address:
City: Milan
Zip: 20122
Country: Italy

Facility:
Name: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Address:
City: Torino
Zip: 10126
Country: Italy

Facility:
Name: Istituto Nazionale Tumori Regina Elena

Address:
City: Rome
Zip: 00144
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Pisana

Address:
City: Pisa
Zip: 56124
Country: Italy

Facility:
Name: Ospedale Le Scotte

Address:
City: Siena
Zip: 53100
Country: Italy

Facility:
Name: Istituto Oncologico Veneto IRCCS

Address:
City: Padova
Zip: 35128
Country: Italy

Facility:
Name: Azienda Ospedaliera Garibaldi

Address:
City: Catania
Zip: 95124
Country: Italy

Facility:
Name: Aichi Cancer Center Hospital

Address:
City: Nagoya
Zip: 464-8681
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa
Zip: 277-8577
Country: Japan

Facility:
Name: Hokkaido University Hospital

Address:
City: Sapporo
Zip: 060-8648
Country: Japan

Facility:
Name: Kobe University Hospital

Address:
City: Kobe
Zip: 650-0017
Country: Japan

Facility:
Name: Yokohama City University Hospital

Address:
City: Yokohama
Zip: 236-0004
Country: Japan

Facility:
Name: Osaka University Hospital

Address:
City: Suita
Zip: 565-0871
Country: Japan

Facility:
Name: Japanese Foundation for Cancer Research

Address:
City: Koto
Zip: 135-8550
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Medical Center

Address:
City: Fukuoka
Zip: 810-8563
Country: Japan

Facility:
Name: Chungbuk National University Hospital

Address:
City: Chungbuk
Zip: 28644
Country: Korea, Republic of

Facility:
Name: National Cancer Center

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam
Zip: 13620
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 3080
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Zip: 3722
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 6351
Country: Korea, Republic of

Facility:
Name: Maastricht UMC+

Address:
City: Maastricht
Zip: 6229 HX
Country: Netherlands

Facility:
Name: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Facility:
Name: Leids Universitair Medisch Centrum

Address:
City: Leiden
Zip: 2333 ZA
Country: Netherlands

Facility:
Name: University Medical Center Groningen

Address:
City: Groningen
Zip: 9713 GR
Country: Netherlands

Facility:
Name: Narodowy Instytut Onkologii - Oddzial w Gliwicach

Address:
City: Gliwice
Zip: 44-101
Country: Poland

Facility:
Name: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Address:
City: Kielce
Zip: 25-734
Country: Poland

Facility:
Name: Clinic Evimed

Address:
City: Chelyabinsk
Zip: 454048
Country: Russian Federation

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

Address:
City: Obninsk
Zip: 249036
Country: Russian Federation

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

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Facility:
Name: Endocrinology Research Center of Rosmedtechnologies

Address:
City: Moscow
Zip: 117292
Country: Russian Federation

Facility:
Name: Saint Petersburg State University

Address:
City: Saint Petersburg
Zip: 190020
Country: Russian Federation

Facility:
Name: Saint-Petersburg City Clinical Oncology Dispensary

Address:
City: Saint Petersburg
Zip: 198255
Country: Russian Federation

Facility:
Name: Hospital Universitari Vall d'Hebron

Address:
City: Barcelona
Zip: 8035
Country: Spain

Facility:
Name: Instituto Catalan de Oncologia - Hospital Duran i Reynals

Address:
City: L'Hospitalet de Llobregat
Zip: 8907
Country: Spain

Facility:
Name: Institut Català d'Oncologia (ICO) - Girona

Address:
City: Girona
Zip: 17007
Country: Spain

Facility:
Name: Clinica Universidad de Navarra

Address:
City: Madrid
Zip: 28027
Country: Spain

Facility:
Name: Hospital Universitario Ramón y Cajal

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hospital Universitario La Paz

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Hospital Universitario Virgen de la Victoria

Address:
City: Malaga
Zip: 29010
Country: Spain

Facility:
Name: Clinica Universidad de Navarra

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: Hospital General Universitario Gregorio Marañon

Address:
City: Madrid
Zip: 28009
Country: Spain

Facility:
Name: Hospital Clinico San Carlos

Address:
City: Madrid
Zip: 28040
Country: Spain

Facility:
Name: Hospital Universitario Miguel Servet

Address:
City: Zaragoza
Zip: 50009
Country: Spain

Facility:
Name: Velindre Cancer Centre

Address:
City: Cardiff
Zip: CF14 2TL
Country: United Kingdom

Facility:
Name: Weston Park Hospital

Address:
City: Sheffield
Zip: S10 2SJ
Country: United Kingdom

Facility:
Name: Gartnavel General Hospital

Address:
City: Glasgow
Zip: g12OYN
Country: United Kingdom

Facility:
Name: Royal Marsden Hospital (Chelsea)

Address:
City: London
Zip: SW3 6JJ
Country: United Kingdom

Facility:
Name: University College London Hospital

Address:
City: London
Zip: NW1 2PG
Country: United Kingdom

Facility:
Name: Royal Marsden Hospital (Sutton)

Address:
City: London
Zip: SM2 5PT
Country: United Kingdom

Start date: February 11, 2020

Completion date: February 28, 2026

Lead sponsor:
Agency: Loxo Oncology, Inc.
Agency class: Industry

Collaborator:
Agency: Eli Lilly and Company
Agency class: Industry

Source: Eli Lilly and Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04211337
https://trials.lillytrialguide.com/en-US/trial/MAk6ymq4v0xp57E7leZ7P