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Clinical Trials in the USA / NCT04211337
Active, not recruiting Phase 3

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

NCT04211337 · tracked via the Priya Life Science USA tracker
Sponsor
Loxo Oncology, Inc.
Phase
Phase 3
Started
2020-02-11
Last updated
2026-03-19

Condition(s) studied

Medullary Thyroid Cancer

Investigational drug(s) / intervention(s)

SelpercatinibCabozantinibVandetanib

Selpercatinib: Administered orally

Cabozantinib: Administered orally

Vandetanib: Administered orally

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
* 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.

Primary outcome measure(s)

Trial sites (143)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
City of Hope National Medical Center Duarte California
UCLA Hematology/Oncology - Westwood (Building 100) Los Angeles California
University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
Emory University Atlanta Georgia
University of Chicago Medical Center Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
University of Michigan Ann Arbor Michigan
Memorial Sloan Kettering Cancer Center New York New York
University of Cincinnati Medical Center Cincinnati Ohio
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio
University of Pennsylvania Hospital Philadelphia Pennsylvania
Thomas Jefferson University Philadelphia Pennsylvania
University of Texas MD Anderson Cancer Center Houston Texas
University of Wisconsin Hospitals and Clinics Madison Wisconsin
Royal North Shore Hospital St Leonards New South Wales
The Alfred Hospital Melbourne Victoria
Peter MacCallum Cancer Centre Melbourne Victoria
Sir Charles Gairdner Hospital Perth Western Australia
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman Liège Belgium
Oncocentro Belo Horizonte Minas Gerais
Hospital de Cancer de Londrina Londrina Paraná
Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul
Fundação Pio XII - Hospital de Câncer de Barretos Barretos São Paulo
Centro de Pesquisa Sao Lucas Campinas São Paulo
Hospital de Clínicas de Ribeirão Preto Ribeirão Preto São Paulo
Hospital Sírio Libanês São Paulo São Paulo
Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo São Paulo
Instituto Nacional de Câncer - INCA Rio de Janeiro Brazil
Grupo Oncoclínicas Botafogo Rio de Janeiro Brazil
Grupo COI - Clínicas Oncológicas Integradas Rio de Janeiro Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo Brazil
Centro Paulista de Oncologia Clínica São Paulo Brazil
Princess Margaret Cancer Centre Toronto Ontario
Anhui Provincial Hospital Hefei Anhui
Beijing Tongren Hospital affiliated to Capital Medical University Beijing Beijing Municipality
Chongqing University Cancer Hospital Chongqing Chongqing Municipality
The First Affiliated Hospital Of Fujian Medical University Fuzhou Fujian
Gansu Cancer Hospital Lanzhou Gansu

+ 103 more sites — see the full list on the official registry below.

On this site

📄 Cabometyx (cabozantinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04211337 on ClinicalTrials.gov ↗ ← All trials in the USA