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

Lilly

Status

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

Treatments: Drug: Selpercatinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03906331

J2G-OX-Y001 (Other Identifier)

17494

Selpercatinib EAP (Other Identifier)

Details and patient eligibility

About

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.

Full description

N/A for expanded access

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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