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Clinical Trial Details — Status: Available

Administrative data

NCT number NCT03906331
Other study ID # 17494
Secondary ID Selpercatinib EA
Status Available
Phase
First received
Last updated

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
Health authority
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
Est. completion date
Est. primary completion date
Accepts healthy volunteers
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

Study Design


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, 

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