A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Sponsor: Loxo Oncology, Inc.
ClinicalTrials ID:NCT04211337
This study evaluates the safety and efficacy of selpercatinib versus standard treatments (cabozantinib, vandetanib) in RET-mutant MTC. It includes an adaptive sample size re-estimation, potentially increasing from 250 to 400 participants based on interim results. Participants may crossover to selpercatinib if disease progresses on standard treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35249 | Birmingham | Alabama |
| City of Hope National Medical Center | 91010-0269 | Duarte | California |
| UCLA Hematology/Oncology - Westwood (Building 100) | 90095 | Los Angeles | California |
| University of California Davis (UC Davis) Comprehensive Cancer Center | 95817 | Sacramento | California |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | 90502 | Torrance | California |
| Emory University | 30322 | Atlanta | Georgia |
| University of Chicago Medical Center | 60637 | Chicago | Illinois |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| Memorial Sloan Kettering Cancer Center | 10017 | New York | New York |
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