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 foran ongoing selpercatinib (also known as LOXO-292) clinical trial or have otherconsiderations 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
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,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 ~ Maximum: N/A
Countries
Australia
France
Germany
Hong Kong
Israel
Italy
Japan
New Zealand
Poland
Singapore
Spain
Switzerland
United States
Locations

Cancer Treatment Centers of America
Goodyear, Arizona, 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
Oakland, 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
Santa Clara, California, United States

Kaiser Permanente Medical Center
Vallejo, California, United States

Memorial Cancer Institute
Hollywood, Florida, United States

Mayo Clinic in Florida
Jacksonville, Florida, United States

Florida Hospital
Orlando, Florida, United States

Tallahassee Memorial Cancer Center
Tallahassee, Florida, United States

University Cancer and Blood Center
Athens, Georgia, United States

Emory University
Atlanta, Georgia, United States

University of Chicago Medicine-Comprehensive Cancer Center
Chicago, Illinois, United States

Cancer Treatment Centers of America
Zion, Illinois, United States

Massachusetts General Hospital
Boston, Massachusetts, United States

Dana-Farber Cancer Institute
Boston, Massachusetts, United States

University of Michigan
Ann Arbor, Michigan, United States

START Midwest
Grand Rapids, Michigan, United States

Mayo Clinic
Rochester, Minnesota, United States

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States

Memorial Sloan Kettering Cancer Center
New York, New York, United States

Cleveland Clinic Foundation
Cleveland, Ohio, United States

Ohio State University Medical Center
Columbus, Ohio, United States

Cancer Treatment Centers of America
Tulsa, Oklahoma, United States

University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States

Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States

Oncology Consultants
Houston, Texas, United States

University of Texas MD Anderson Cancer Center
Houston, Texas, United States

Virginia Cancer Specialists
Fairfax, Virginia, United States

University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, United States

NSW Health - Sydney Local Health District
Camperdown, New South Wales, Australia

Royal North Shore Hospital
St. Leonards, New South Wales, Australia

Queensland Health - Metro North Hospital and Health Service
Chermside, Queensland, Australia

Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia

Linear Clinical Research
Nedlands, Western Australia, Australia

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, France

AP-HM
Marseille, France

Gustave Roussy
Villejuif Cedex, France

Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bayern, Germany

Universitätsklinikum Köln
Köln, Nordrhein-Westfalen, Germany

Charité Campus Virchow-Klinikum
Berlin, Germany

Prince of Wales Hospital
Hong Kong, Shatin, New Territories, Hong Kong

Sheba Medical Center
Ramat Gan, HaMerkaz, Israel

Shaare Zedek Medical Center
Jerusalem, Yerushalayim, Israel

Soroka Medical Center - Pediatric Outpatient Clinic
Beer-Sheva, Israel

Istituto Nazionale dei Tumori
Milano, Lombardie, Italy

Azienda Ospedaliero Universitaria Pisana
Pisa, PI, Italy

National Cancer Center Hospital East
Kashiwa, Chiba, Japan

Hokkaido University Hospital
Sapporo, Hokkaido, Japan

Kanazawa University Hospital
Kanazawa, Ishikawa, Japan

National Cancer Center Hospital
Chuo-ku, Tokyo, Japan

Tottori University Hospital
Yonago, Tottori, Japan

Osaka City General Hospital
Osaka, Japan

University of Auckland
Auckland, New Zealand

Uniwersyteckie Centrum Kliniczne
Gdansk, Poland

Centrum Onkologii Instytut im Marii Curie w Warszawie
Warszawa, Poland

National Cancer Centre Singapore
Singapore, Central Singapore, Singapore

Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain

Hospital Madrid Norte Sanchinarro
Madrid, Spain

Kantonsspital Luzern
Luzern 16, Luzern, Switzerland

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

Eli Lilly and Company
NCT Number
MeSH Terms
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases