Expanded Access For The Treatment Of Cancers With Rearranged During Transfection (RET) Activation

Study Overview

Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

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.

N/A for expanded access

Non Small Cell Lung Cancer
Medullary Thyroid Cancer
Colon Cancer
Breast Cancer
Pancreatic Cancer
Papillary Thyroid Cancer
Other Solid Tumors With Evidence of Activating RET Alteration

DRUG: Selpercatinib

17494
Selpercatinib EAP (OTHER Identifier) (OTHER: Loxo Oncology, Inc.)
J2G-OX-Y001 (OTHER Identifier) (OTHER: Eli Lilly and Company)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-04-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-16
First Submitted that Met QC Criteria 2019-04-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-17
First Posted (ACTUAL) 2019-04-08	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record