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A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

Primary Purpose

Medullary Thyroid Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Selpercatinib
Cabozantinib
Vandetanib
Sponsored by
Loxo Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medullary Thyroid Cancer focused on measuring medullary thyroid carcinoma, targeted therapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic in Arizona - Phoenix
  • City of Hope National Medical Center
  • University of California San Diego
  • UCLA Hematology/Oncology - Westwood (Building 100)
  • University of California Davis (UC Davis) Comprehensive Cancer Center
  • UCSF Medical Center at Mission Bay
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Mayo Clinic in Florida
  • Emory University
  • University of Chicago Medical Center
  • Massachusetts General Hospital
  • University of Michigan
  • Karmanos Cancer Institute
  • Mayo Clinic in Rochester, Minnesota
  • Washington University
  • Memorial Sloan Kettering Cancer Center
  • University of Cincinnati Medical Center
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
  • Providence Cancer Center Oncology Hematology Care
  • University of Pennsylvania Hospital
  • Thomas Jefferson University
  • UPMC Hillman Cancer Center
  • University of Texas MD Anderson Cancer Center
  • University of Wisconsin Hospitals and Clinics
  • Chris O'Brien Lifehouse
  • Royal North Shore Hospital
  • The Alfred Hospital
  • Peter MacCallum Cancer Centre
  • Sir Charles Gairdner Hospital
  • Antwerp University Hospital
  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
  • Oncocentro
  • Hospital de Cancer de Londrina
  • Hospital de Clinicas de Porto Alegre
  • Fundação Pio XII - Hospital de Câncer de Barretos
  • Centro de Pesquisa Sao Lucas
  • Hospital de Clínicas de Ribeirão Preto
  • Hospital Sírio Libanês
  • Instituto D'Or de Pesquisa e Ensino (IDOR)
  • Instituto Nacional de Câncer - INCA
  • Grupo Oncoclínicas Botafogo
  • Grupo COI - Clínicas Oncológicas Integradas
  • Icesp - Instituto Do Câncer Do Estado de São Paulo
  • Centro Paulista de Oncologia Clínica
  • Princess Margaret Cancer Centre
  • Anhui Provincial Hospital
  • Beijing Tongren Hospital affiliated to Capital Medical University
  • Chongqing University Cancer Hospital
  • The First Affiliated Hospital Of Fujian Medical University
  • Gansu Cancer Hospital
  • Sun Yat-Sen University Cancer Centre
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • Hunan Cancer Hospital
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Jilin Cancer Hospital
  • Jinan Central Hospital
  • Fudan University Shanghai Cancer Center
  • West China Hospital, Sichuan University
  • Tianjin Medical University Cancer Institute and Hospital
  • First Affiliated Hospital of Kunming Medical University
  • Zhejiang Provincial People's Hospital
  • Sir Run Run Shaw Hospital
  • Zhejiang Cancer Hospital
  • Fakultní nemocnice Brno Bohunice
  • Fakultni nemocnice Motol
  • Fakultni nemocnice Olomouc
  • Centre Paul Strauss
  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
  • Centre François Baclesse
  • Centre Georges François Leclerc
  • Institut Claudius Regaud
  • Centre Hospitalier Universitaire d'Angers
  • Hopital Claude Huriez - CHU de Lille
  • Pitie Salpetriere University Hospital
  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
  • Centre Leon Berard
  • Gustave Roussy
  • Klinikum der Universität München Großhadern
  • Klinikum der Universität München Großhadern
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Essen
  • Universitätsmedizin Johannes Gutenberg Universität Mainz
  • Otto-von-Guericke-Universität Magdeburg
  • Charité Universitaetsmedizin Berlin - Campus Mitte
  • Hämato-Onkologie Hamburg, Prof. Laack und Partner
  • Alexandra General Hospital of Athens
  • University General Hospital of Heraklion
  • European Interbalkan Medical Center
  • Regional Cancer Centre - Thiruvananthapuram
  • HCG Manavata Cancer Centre
  • Grant Medical Foundation - Ruby Hall Clinic
  • Deenanath Mangeshkar Hospital & Research Centre
  • Apollo Gleneagles Hospitals Kolkata
  • Post Graduate Institute of Medical Education & Research (PGIMER)
  • Rabin Medical Center
  • Sheba Medical Center
  • Hadassah Medical Center
  • University of Naples Federico II
  • Policlinico Umberto I
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Auxologico Italiano
  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
  • Istituto Nazionale Tumori Regina Elena
  • Azienda Ospedaliera Universitaria Pisana
  • Ospedale Le Scotte
  • Istituto Oncologico Veneto IRCCS
  • Azienda Ospedaliera Garibaldi
  • Aichi Cancer Center Hospital
  • National Cancer Center Hospital East
  • Hokkaido University Hospital
  • Kobe University Hospital
  • Yokohama City University Hospital
  • Osaka University Hospital
  • Japanese Foundation for Cancer Research
  • National Hospital Organization Kyushu Medical Center
  • Chungbuk National University Hospital
  • Asan Medical Center
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Maastricht UMC+
  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
  • Leids Universitair Medisch Centrum
  • University Medical Center Groningen
  • Narodowy Instytut Onkologii - Oddzial w Gliwicach
  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Clinic Evimed
  • A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
  • Endocrinology Research Center of Rosmedtechnologies
  • Saint Petersburg State University
  • Saint-Petersburg City Clinical Oncology Dispensary
  • Hospital Universitari Vall d'Hebron
  • Instituto Catalan de Oncologia - Hospital Duran i Reynals
  • Institut Català d'Oncologia (ICO) - Girona
  • Clinica Universidad de Navarra
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen de la Victoria
  • Clinica Universidad de Navarra
  • Hospital General Universitario Gregorio Marañon
  • Hospital Clinico San Carlos
  • Hospital Universitario Miguel Servet
  • China Medical University Hospital
  • National Cheng-Kung Uni. Hosp.
  • National Taiwan University Hospital
  • Velindre Cancer Centre
  • Weston Park Hospital
  • Gartnavel General Hospital
  • Royal Marsden Hospital (Chelsea)
  • University College London Hospital
  • Royal Marsden NHS Trust
  • Royal Marsden Hospital (Sutton)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Selpercatinib

Cabozantinib or Vandetanib

Arm Description

Selpercatinib given orally.

Cabozantinib or vandetanib given orally.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) by BICR
PFS by BICR

Secondary Outcome Measures

Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)
TFFS by BICR
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR
ORR: Percentage of Participants with CR or PR by BICR
Duration of Response (DoR) by BICR
DoR by BICR
Overall Survival (OS)
OS
PFS2 by Investigator
PFS2 by Investigator
Comparative Tolerability: Percentage of Time with High Side Effect Bother Based on the Functional Assessment of Cancer Therapy-Side Effects (FACT-GP5)
FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer. The single FACT-G item, GP5, "I am bothered by side effects of treatment," is a summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of adverse events in clinical trials. It uses a 5-point rating scale (0="not at all" and 4=equals "very much"). Higher GP5 scores indicates more bother from side effects
The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)
The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)

Full Information

First Posted
December 24, 2019
Last Updated
August 28, 2023
Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04211337
Brief Title
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Acronym
LIBRETTO-531
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
November 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medullary Thyroid Cancer
Keywords
medullary thyroid carcinoma, targeted therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selpercatinib
Arm Type
Experimental
Arm Description
Selpercatinib given orally.
Arm Title
Cabozantinib or Vandetanib
Arm Type
Active Comparator
Arm Description
Cabozantinib or vandetanib given orally.
Intervention Type
Drug
Intervention Name(s)
Selpercatinib
Other Intervention Name(s)
LY3527723, LOXO-292
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) by BICR
Description
PFS by BICR
Time Frame
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 30 Months)
Secondary Outcome Measure Information:
Title
Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)
Description
TFFS by BICR
Time Frame
Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause (Estimated at up to 30 Months)
Title
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR
Description
ORR: Percentage of Participants with CR or PR by BICR
Time Frame
Baseline through Disease Progression or Death (Estimated at up to 30 Months)
Title
Duration of Response (DoR) by BICR
Description
DoR by BICR
Time Frame
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 30 Months)
Title
Overall Survival (OS)
Description
OS
Time Frame
Baseline to Date of Death from Any Cause (Estimated at up to 60 Months)
Title
PFS2 by Investigator
Description
PFS2 by Investigator
Time Frame
Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 48 Months)
Title
Comparative Tolerability: Percentage of Time with High Side Effect Bother Based on the Functional Assessment of Cancer Therapy-Side Effects (FACT-GP5)
Description
FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer. The single FACT-G item, GP5, "I am bothered by side effects of treatment," is a summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of adverse events in clinical trials. It uses a 5-point rating scale (0="not at all" and 4=equals "very much"). Higher GP5 scores indicates more bother from side effects
Time Frame
Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause (30 months)
Title
The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)
Description
The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Mayo Clinic in Arizona - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-0269
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCLA Hematology/Oncology - Westwood (Building 100)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis (UC Davis) Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF Medical Center at Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence Cancer Center Oncology Hematology Care
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232-1305
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Hospitals and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Oncocentro
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30380-680
Country
Brazil
Facility Name
Hospital de Cancer de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86015-520
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784400
Country
Brazil
Facility Name
Centro de Pesquisa Sao Lucas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Hospital de Clínicas de Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Hospital Sírio Libanês
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01308-060
Country
Brazil
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04543-000
Country
Brazil
Facility Name
Instituto Nacional de Câncer - INCA
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Grupo Oncoclínicas Botafogo
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Grupo COI - Clínicas Oncológicas Integradas
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
Icesp - Instituto Do Câncer Do Estado de São Paulo
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Centro Paulista de Oncologia Clínica
City
São Paulo
ZIP/Postal Code
01452-000
Country
Brazil
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230071
Country
China
Facility Name
Beijing Tongren Hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
The First Affiliated Hospital Of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Gansu Cancer Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Facility Name
Sun Yat-Sen University Cancer Centre
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital, Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Fakultní nemocnice Brno Bohunice
City
Brno
State/Province
Brno-město
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Motol
City
Praha
State/Province
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Centre Paul Strauss
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33076
Country
France
Facility Name
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13915
Country
France
Facility Name
Centre François Baclesse
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
State/Province
Côte-d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Claude Huriez - CHU de Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Pitie Salpetriere University Hospital
City
Paris
State/Province
Orne
ZIP/Postal Code
75013
Country
France
Facility Name
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Leon Berard
City
Lyon
State/Province
Rhône-Alpes
ZIP/Postal Code
69008
Country
France
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Klinikum der Universität München Großhadern
City
München
State/Province
Bayern
ZIP/Postal Code
81337
Country
Germany
Facility Name
Klinikum der Universität München Großhadern
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsmedizin Johannes Gutenberg Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Otto-von-Guericke-Universität Magdeburg
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Charité Universitaetsmedizin Berlin - Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Hämato-Onkologie Hamburg, Prof. Laack und Partner
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Alexandra General Hospital of Athens
City
Athina
State/Province
Attikí
ZIP/Postal Code
115 28
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Irakleío
ZIP/Postal Code
711 10
Country
Greece
Facility Name
European Interbalkan Medical Center
City
Thessaloníki
State/Province
Thessaloniki
ZIP/Postal Code
570 01
Country
Greece
Facility Name
Regional Cancer Centre - Thiruvananthapuram
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
HCG Manavata Cancer Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422001
Country
India
Facility Name
Grant Medical Foundation - Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Apollo Gleneagles Hospitals Kolkata
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Post Graduate Institute of Medical Education & Research (PGIMER)
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Rabin Medical Center
City
Petah-Tikva
State/Province
HaMerkaz
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
State/Province
HaMerkaz
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Facility Name
University of Naples Federico II
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico Umberto I
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Auxologico Italiano
City
Milan
State/Province
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Rome
State/Province
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
Ospedale Le Scotte
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Istituto Oncologico Veneto IRCCS
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Garibaldi
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Chungbuk National University Hospital
City
Chungbuk
State/Province
Chungcheongbuk-do [Chungbuk]
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyǒnggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GR
Country
Netherlands
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach
City
Gliwice
State/Province
Śląskie
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Kielce
State/Province
Świętokrzyskie
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Clinic Evimed
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast'
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
City
Obninsk
State/Province
Kalužskaja Oblast'
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Endocrinology Research Center of Rosmedtechnologies
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Saint Petersburg State University
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
190020
Country
Russian Federation
Facility Name
Saint-Petersburg City Clinical Oncology Dispensary
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
8035
Country
Spain
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
8907
Country
Spain
Facility Name
Institut Català d'Oncologia (ICO) - Girona
City
Girona
State/Province
Girona [Gerona]
ZIP/Postal Code
17007
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng-Kung Uni. Hosp.
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Velindre Cancer Centre
City
Cardiff
State/Province
Cardiff [Caerdydd Gb-crd]
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Gartnavel General Hospital
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
g12OYN
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Chelsea)
City
London
State/Province
Kensington And Chelsea
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
University College London Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton)
City
London
State/Province
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Citations:
PubMed Identifier
35969032
Citation
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.
Results Reference
derived
PubMed Identifier
34292174
Citation
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.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/MAk6ymq4v0xp57E7leZ7P
Description
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

Learn more about this trial

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

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