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

Available
Individual Patients
Treatment IND/Protocol
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
Open-label expanded access
Other Name: LOXO-292
Other Name: LY3527723

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Australia
France
Germany
Hong Kong
Israel
Italy
Japan
Netherlands
New Zealand
Poland
Singapore
Spain
Switzerland
United States
Locations

Cancer Treatment Centers of America
Goodyear, Arizona, 85338

Available

Contact: 623-207-3000

Investigator: Ashish Sangal

Mayo Clinic of Scottsdale
Scottsdale, Arizona, 85259

Available

Contact: 480-301-8000

Investigator: Nina Karlin, MD

City of Hope National Medical Center
Duarte, California, 91010

Available

Investigator: Erminia Massarelli
Contact: 626-256-4673

Investigator: Erminia Massarelli

University of California - San Diego
La Jolla, California, 92103

Available

Contact: 858-534-2230

Investigator: Lyudmia Bazhenova

UCLA Medical Center
Los Angeles, California, 90095

Available

Contact: 310-794-1816

Investigator: Mykola Onshchenko, MD

Kaiser Permanente
Oakland, California, 94612

Available

Investigator: Jennifer Suga

Irvine Medical Center
Orange, California, 92868

Available

Contact: 714-456-8000

Investigator: Viola Zhu

Kaiser Permanente Medical Center
Sacramento, California, 95814

Available

Investigator: Jennifer Suga

Kaiser Permanente Medical Center
San Francisco, California, 94115

Available

Investigator: Jennifer Suga

Univ of California San Francisco
San Francisco, California, 94115

Available

Contact: 415-353-7552

Investigator: Alain Algazi

Kaiser Permanente
Santa Clara, California, 95051

Available

Investigator: Jennifer Suga

UCLA Medical Center
Santa Monica, California, 90404

Available

Contact: 310-633-9400

Investigator: Jonathan Goldman

Kaiser Permanente Medical Center
Vallejo, California, 94589

Available

Contact: 510-891-3414

Investigator: Jennifer Suga

Memorial Cancer Institute
Hollywood, Florida, 33021

Available

Investigator: Luis Raez
Contact: 305-243-1000

Investigator: Luis Raez

Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224

Available

Contact: 904-953-2000

Investigator: Victor Bernet, MD

Florida Hospital
Orlando, Florida, 32803

Available

Contact: 407-303-0409

Investigator: Mark Socinski

Tallahassee Memorial Hospital
Tallahassee, Florida, 32308

Available

Contact: 850-431-5360

Investigator: Karen Russell

University Cancer and Blood Center
Athens, Georgia, 30607

Available

Contact: 706-353-2990

Investigator: Petros Nikolinakos

Emory University
Atlanta, Georgia, 30329

Available

Contact: 404-727-6123

Investigator: Taofeek Owonikoko

University of Chicago Medicine-Comprehensive Cancer Center
Chicago, Illinois, 60637

Available

Contact: 630-862-5757

Investigator: Christine Bestvina

Cancer Treatment Centers of America, Chicago
Zion, Illinois, 60099

Available

Contact: 847-872-6324

Investigator: Eugene Ahn

Massachusetts General Hospital
Boston, Massachusetts, 02114

Available

Contact: 617-726-2515

Investigator: Lori Wirth

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215

Available

Contact: 617-632-5869

Investigator: Geoffrey Oxnard

University of Michigan
Ann Arbor, Michigan, 48109

Available

Contact: 734-647-8902

Investigator: Francis Worden

START Midwest
Grand Rapids, Michigan, 49546

Available

Contact: 616-954-5554

Investigator: Nehal Lakhani

Mayo Clinic
Rochester, Minnesota, 55905

Available

Contact: 507-284-4080

Investigator: John Morris

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169

Available

Contact: 702-952-3400

Investigator: Fadi Braiteh

Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Available

Contact: 646-888-4206

Investigator: Alexander Drilon

Cleveland Clinic Foundation
Cleveland, Ohio, 44195

Available

Contact: 216-444-1128

Investigator: Nathan Pennell

Ohio State University Medical Center
Columbus, Ohio, 43210

Available

Contact: 614-293-3873

Investigator: Manisah Shah

Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133

Available

Contact: 918-286-5689

Investigator: Issam Alawin

University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104

Available

Investigator: Marcia Brose
Contact: 215-898-8796

Investigator: Marcia Brose

Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124

Available

Contact: 215-537-4555

Investigator: Arturo Loaiza-Bonilla

Oncology Consultants
Houston, Texas, 77030

Available

Contact: 713-797-6323

Investigator: Julio Peguero

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030

Available

Contact: 713-745-6754

Investigator: Vivek Subbiah

Virginia Cancer Specialists
Fairfax, Virginia, 22031

Available

Contact: 703-280-5390

Investigator: Alexander Spira

University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, 53792-4108

Available

Investigator: Mark Burkard

Contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Study Director
Eli Lilly and Company

Loxo Oncology, Inc.
Eli Lilly and Company
NCT Number
MeSH Terms
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Intervention Name
Selpercatinib