Study on Selpercatinib for Patients with RET-Mutant Medullary Thyroid Cancer
Sponsor: Loxo Oncology, Inc.
ClinicalTrials ID:NCT04211337
This clinical trial is testing whether the drug selpercatinib is safe and more effective than standard treatments for patients with RET-mutant medullary thyroid cancer that cannot be surgically removed or has spread to other parts of the body. Patients who do not respond to the standard treatment may have the option to switch to selpercatinib.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if selpercatinib is a safe and effective treatment for patients with medullary thyroid cancer (MTC) that has a specific genetic mutation called RET. This type of cancer cannot be removed by surgery or has spread to other areas. The study will compare selpercatinib to the standard treatment to see which works better. If patients on the standard treatment do not improve, they may have the chance to switch to selpercatinib.
Description
The study will involve an initial analysis to decide if more participants are needed, potentially increasing the number from about 250 to 400 based on early results. This approach helps ensure the study has enough participants to provide reliable results.
Eligibility Criteria
Exclusion Criteria
- Have another known genetic mutation in the cancer that could make selpercatinib less effective, such as RAS or BRAF mutations.
- Have cancer that has spread to the brain or spinal cord and is causing symptoms, or have untreated spinal cord compression.
- Have serious heart problems, such as recent heart attack or certain heart rhythm issues.
- Have an active, uncontrolled infection or other serious illness.
- Have active bleeding or a high risk of bleeding.
- Have another type of cancer, unless it is a non-threatening skin cancer or was diagnosed over two years ago and is not currently active. Patients with a specific condition called multiple endocrine neoplasia type 2 (MEN2) may still 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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