Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Sponsor: Eli Lilly and Company
ClinicalTrials ID:NCT03906331
This expanded access program provides selpercatinib to cancer patients with RET activation who are ineligible for ongoing trials. Eligible patients must have progressed on standard therapy or lack viable options, and have adequate organ function. Exclusions include participation in other selpercatinib studies and significant cardiovascular issues.
Patient Parameters
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Program Overview
Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial.
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
Description
N/A for expanded access
Eligibility Criteria
Inclusion Criteria
- Diagnosis of cancer with RET activation, who are not eligible for an ongoing selpercatinib clinical trial and are medically suitable for treatment with selpercatinib
- Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
- Have adequate organ function
Exclusion Criteria
- Currently enrolled in an ongoing clinical study of selpercatinib or another RET inhibitor
- Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds
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