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

• Conditions: 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

• Registration Number: NCT03906331
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

N/A for expanded access

Study Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-08
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (61)

Cancer Treatment Centers of America; 🇺🇸 Tulsa, Oklahoma, United States

Mayo Clinic of Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente; 🇺🇸 Santa Clara, California, United States

Irvine Medical Center; 🇺🇸 Orange, California, United States

University of California - San Diego; 🇺🇸 San Diego, California, United States

Univ of California San Francisco; 🇺🇸 San Francisco, California, United States

Kaiser Permanente Medical Center; 🇺🇸 Vallejo, California, United States

Memorial Cancer Institute; 🇺🇸 Hollywood, Florida, United States

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