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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT03906331
• Other study ID #: 17494
• Secondary ID: Selpercatinib EA
• Status: Available

Study information

• Verified date: September 15, 2023
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Description:

N/A for expanded access

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Selpercatinib
Open-label expanded access

Locations

Country	Name	City	State
Australia	NSW Health - Sydney Local Health District	Camperdown	New South Wales
Australia	Queensland Health - Metro North Hospital and Health Service	Chermside	Queensland
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
France	Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest	Bordeaux	Aquitaine
France	AP-HM	Marseille
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Universitätsklinikum Köln	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Würzburg A. ö. R.	Würzburg	Bayern
Israel	Soroka Medical Center - Pediatric Outpatient Clinic	Beer-Sheva
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Italy	ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C	Milano
Italy	Istituto Nazionale dei Tumori	Milano	Lombardie
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa	PI
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Osaka City General Hospital	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tottori University Hospital	Yonago	Tottori
New Zealand	University of Auckland	Auckland
Poland	Centrum Onkologii Instytut im Marii Curie w Warszawie	Warszawa
Singapore	National Cancer Centre Singapore	Singapore	Central Singapore
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Switzerland	Kantonsspital Luzern	Luzern 16	Luzern
United States	University of Michigan	Ann Arbor	Michigan
United States	University Cancer and Blood Center	Athens	Georgia
United States	Emory University	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago Medicine-Comprehensive Cancer Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	City of Hope National Medical Center	Duarte	California
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Cancer Treatment Centers of America	Goodyear	Arizona
United States	START Midwest	Grand Rapids	Michigan
United States	Memorial Cancer Institute	Hollywood	Florida
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	University of Wisconsin-Madison Hospital and Health Clinic	Madison	Wisconsin
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Irvine Medical Center	Orange	California
United States	Florida Hospital	Orlando	Florida
United States	Eastern Regional Medical Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California - San Diego	San Diego	California
United States	Univ of California San Francisco	San Francisco	California
United States	Mayo Clinic of Scottsdale	Scottsdale	Arizona
United States	Tallahassee Memorial Cancer Center	Tallahassee	Florida
United States	Cancer Treatment Centers of America	Tulsa	Oklahoma
United States	Cancer Treatment Centers of America	Zion	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loxo Oncology, Inc.	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Israel,  Italy,  Japan,  New Zealand,  Poland,  Singapore,  Spain,  Switzerland,