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

Study acronym: LIBRETTO-531
StatusActive, Not Recruiting
PhasePhase 3
Started2020-02-11
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 80 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-03-02
Study Status v79
Completion date2026-02→2027-11
2025-04-17
2 amendments v77-v78
2 re-verifications since 2025-02-26, no change to tracked fields
2025-01-15
Study Status, Outcome Measures, Outcome Measures (Results), Adverse Events v76
Completion date2026-02-28→2026-02
Secondary endpointsdetails revised at 6 of 7 entries
2024-05-20
Study Status, Arms and Interventions, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v75
Results first postednot stated→2024-06-13
Secondary endpoints7 entries, revised
Comparative Tolerability: PercentageNumber of TimeWeeks With High Side Effect Bother Based Score of 3 or 4 on the Functional Assessment of Cancer Therapy-Side EffectsItem GP5 (FACT-GP5)
2024-03-12
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v74
Study sites159→143
Secondary endpoints7 entries, revised
Overall Response Rate (ORR): Percentage of Participants withWith Complete Response (CR) or Partial Response (PR) by BICR Comparative Tolerability: Percentage of Time withWith High Side Effect Bother Based on the Functional Assessment [...] and the Central Lab RET Results: Percentage of Participants withWith RET-Positive Specimens as Called by the Central Lab, whichWhich is alsoAlso RET-Positive as Called by a Local Lab (Positive Percent Agreement)
Primary endpoints1 entry, revised
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Show 44 earlier versions
2024-01-17
Study Status v73
Completion date2026-02→2026-02-28
2023-10-26
Completed→Active, Not Recruiting Study Status v72
Trial statusCompleted→Active, Not Recruiting
Completion date2023-05-22→2026-02
2023-10-25
Active, Not Recruiting→Completed Study Status, Study Design v71
Trial statusActive, Not Recruiting→Completed
Completion dateestimated 2026-11-13→confirmed 2023-05-22
Enrollment targetestimated 400→confirmed 291
2023-08-28
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v70
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-05-20→confirmed 2023-05-22
Study sites149→159
2023-07-12
Study Status, Contacts/Locations v69
Study sitescontacts updated at 1 of 149 sites
2023-05-23
Study Status, Contacts/Locations v68
Study sites149 entries, revised
PostgraduatePost Graduate Institute of Medical Education & Research (PGIMER) 'Hospital Universitario Virgen de la Victoria
2023-04-16
Study Status, Contacts/Locations v67
Study sitesdetails revised at 2 of 149 sites
2023-04-12
Study Status v66
Re-verified, no change to tracked fields
2023-03-24
Study Status, Contacts/Locations v65
Study sites149 entries, revised
Oncocentro BH
2023-03-07
Study Status, Contacts/Locations v64
Study sitescontacts updated at 2 of 149 sites
2023-02-22
Study Status, Contacts/Locations v63
Study sites149 entries, revised
ThomasSidney JeffersonKimmel UniversityCtr. for Urologic & Prostate Cancers, MSKCC National Cheng- Kung Uni.University Hosp.Hospital
2023-01-18
2 amendments v61-v62
2 re-verifications since 2023-01-10, no change to tracked fields
2022-12-26
Study Status, Contacts/Locations v60
Study sites149 entries, revised
Princess Margaret Hospital (Ontario)
2022-12-09
2 amendments v58-v59
2 re-verifications since 2022-11-23, no change to tracked fields
2022-11-10
Study Status, Contacts/Locations v57
Study sitesdetails revised at 4 of 149 sites
2022-10-18
Study Status, Contacts/Locations v56
Study sites154→149
2022-10-11
Study Status, Contacts/Locations v55
Study sitesdetails revised at 1 of 154 sites
2022-09-08
Study Status, Contacts/Locations v54
Study sitescontacts updated at 1 of 154 sites
2022-08-17
Study Status, Contacts/Locations v53
Study sites154 entries, revised
MayoRoyal ClinicMarsden NHS Trust
2022-08-08
Study Status, Contacts/Locations v52
Study sitescontacts updated at 1 of 154 sites
2022-07-19
2 amendments v50-v51
2 re-verifications since 2022-07-07, no change to tracked fields
2022-06-22
Study Status, Contacts/Locations v49
Study sites155→154
2022-06-09
Study Status, Contacts/Locations v48
Study sitesdetails revised at 4 of 155 sites
2022-05-20
Study Status, Contacts/Locations v47
Study sitescontacts updated at 1 of 155 sites
2022-04-18
Study Status, Contacts/Locations v46
Study sitesdetails revised at 1 of 155 sites
2022-04-06
Study Status, Contacts/Locations v45
Study sites156→155
2022-03-01
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v44
Study sites158→156
Eligibility criteria+4 characters
[...] nded to receive vandetanib if randomized to the control arm are ineligible if QTcF is >450 milliseconds. Active uncontrolled [...]
Secondary endpoints7 entries, revised
ProgressionTreatment Failure-Free Survival (PFSTFFS) by Blinded Independent Committee Review (BICR)
Primary endpoints1 entry, revised
TreatmentProgression Failure-Free Survival (TFFSPFS) by Blinded Independent Committee Review (BICR)
Study description+184 characters
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.
2021-12-08
Study Status, Contacts/Locations v43
Study sites158 entries, revised
Post GraduatePostgraduate Institute of Medical Education & Research
2021-11-17
Study Status, Contacts/Locations v42
Study sites158 entries, revised
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne UniversitätsklinikumUniversitaetsklinikum Essen Hospital Universitario RamonRamón y Cajal Hospital General Universitario Gregorio MaranonMarañon
2021-11-08
Study Status, Contacts/Locations v41
Study sites158 entries, revised
InstitutoGrupo COI de- PesquisaClínicas EducaçãoOncológicas e GestãoIntegradas Fundação PIOPio XII - Hospital de Câncer de Barretos CHUCentre Hospitalier Universitaire d'Angers TheJapanese Foundation for Cancer Institute Hospital of JFCRResearch
2021-10-15
Study Status v40
Re-verified, no change to tracked fields
2021-10-05
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 158 sites
2021-09-20
Study Status, Contacts/Locations v38
Study sites159→158
2021-09-02
Study Status, Contacts/Locations v37
Study sites160→159
2021-08-17
Study Status, Contacts/Locations v36
Study sites160 entries, revised
BeijingLLC Peking Union Medical College HospitalEvimed
2021-08-04
Study Status, Contacts/Locations v35
Study sites160 entries, revised
TheThomas FifthJefferson Medical Center of PLA General HospitalUniversity
2021-07-15
Study Status, Contacts/Locations v34
Study sites160 entries, revised
Institut BergonieBergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest St. Saint-Petersburg City Clinical OncologicalOncology Dispensary
2021-07-06
Study Status, Contacts/Locations v33
Study sites160 entries, revised
Centre Georges FrancoisFrançois Leclerc Institut Claudius Regaud - IUCT Oncopole
2021-06-17
Study Status, Contacts/Locations v32
Study sites158→160
2021-06-07
Study Status, Contacts/Locations v31
Study sites158 entries, revised
Mayo Clinic of ScottsdaleHospital
2021-05-18
Study Status, Contacts/Locations v30
Study sitesdetails revised at 2 of 158 sites
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.
Trial Details
NCT Number NCT04211337
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Medullary Thyroid Cancer
Enrollment 291 participants
Start Date 2020-02-11
Primary Completion 2023-05-22 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-03-19