Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
NCT ID: NCT03906331
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
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Detailed Description
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Conditions
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Interventions
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Selpercatinib
Open-label expanded access
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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, , France
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bavaria, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, Germany
Charité Campus Virchow-Klinikum
Berlin, , Germany
Prince of Wales Hospital
Hong Kong, Shatin, New Territories, Hong Kong
Sheba Medical Center
Ramat Gan, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba, , Israel
Istituto Nazionale dei Tumori
Milan, Lombardy, 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-ken, 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
Warsaw, , 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
Lucerne, Canton of Lucerne, Switzerland
Countries
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References
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Rotow J, Patel JD, Hanley MP, Yu H, Awad M, Goldman JW, Nechushtan H, Scheffler M, Kuo CS, Rajappa S, Harada G, Clifford S, Santucci A, Silva L, Tupper R, Oxnard GR, Kherani J, Drilon A. Osimertinib and Selpercatinib Efficacy, Safety, and Resistance in a Multicenter, Prospectively Treated Cohort of EGFR-Mutant and RET Fusion-Positive Lung Cancers. Clin Cancer Res. 2023 Aug 15;29(16):2979-2987. doi: 10.1158/1078-0432.CCR-22-2189.
Murciano-Goroff YR, Falcon CJ, Lin ST, Chacko C, Grimaldi G, Liu D, Wilhelm C, Iasonos A, Drilon A. Central Nervous System Disease in Patients With RET Fusion-Positive NSCLC Treated With Selpercatinib. J Thorac Oncol. 2023 May;18(5):620-627. doi: 10.1016/j.jtho.2023.01.008. Epub 2023 Jan 16.
Other Identifiers
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Selpercatinib EAP
Identifier Type: OTHER
Identifier Source: secondary_id
J2G-OX-Y001
Identifier Type: OTHER
Identifier Source: secondary_id
17494
Identifier Type: -
Identifier Source: org_study_id
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