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

Running, not enrolling · Phase 3

Conditions studied: Medullary Thyroid Cancer

In brief

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.

Key facts

Study ID

NCT04211337

Run by

Loxo Oncology, Inc.

People needed

291

Starts

2020-02-11

Expected to finish

2027-11-01

Last updated by the study team

2026-03-19

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• UCLA Hematology/Oncology - Westwood (Building 100) — Los Angeles, California, United States
• University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Wisconsin Hospitals and Clinics — Madison, Wisconsin, United States
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Sir Charles Gairdner Hospital — Perth, Western Australia, Australia
• Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman — Liège, Belgium
• Oncocentro — Belo Horizonte, Minas Gerais, Brazil
• Hospital de Cancer de Londrina — Londrina, Paraná, Brazil
• Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
• Fundação Pio XII - Hospital de Câncer de Barretos — Barretos, São Paulo, Brazil
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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