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

Last updated: January 16, 2025
Sponsor: Eli Lilly and Company
Overall Status: Planned

Phase

N/A

Condition

Breast Cancer

Pancreatic Cancer

Pancreatic Disorders

Treatment

Selpercatinib

Clinical Study ID

NCT03906331
17494
J2G-OX-Y001
Selpercatinib EAP
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of cancer with RET activation, who are not eligible for an ongoingselpercatinib clinical trial and are medically suitable for treatment withselpercatinib

  • Have progressed or are intolerant to standard therapy, or no standard therapy optionexists, or in the opinion of the investigator, are unlikely to derive significantclinical benefit from standard therapy

  • Have adequate organ function

Exclusion

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study of selpercatinib or another RETinhibitor

  • Clinically significant active cardiovascular disease or history of myocardialinfarction within 6 months prior to study treatment; ongoing cardiomyopathy; orcurrent prolongation of the QT interval corrected for heart rate using Fridericia'sformula (QTcF) interval greater than 470 milliseconds

Study Design

Treatment Group(s): 1
Primary Treatment: Selpercatinib
Phase:
Study Start date:
Estimated Completion Date:

Study Description

N/A for expanded access

Connect with a study center

  • NSW Health - Sydney Local Health District

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St. Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Queensland Health - Metro North Hospital and Health Service

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine 33076
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux Cedex, 33076
    France

    Site Not Available

  • Centre Leon Berard

    Lyon Cedex 08, 69008
    France

    Site Not Available

  • AP-HM

    Marseille, 13005
    France

    Site Not Available

  • Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Universitätsklinikum Würzburg A. ö. R.

    Würzburg, Bayern 97080
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Charité Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong, Shatin, New Territories 999077
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Shatin,
    Hong Kong

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9103102
    Israel

    Site Not Available

  • Soroka University Medical Center

    Be'er Sheva, 8410101
    Israel

    Site Not Available

  • Soroka Medical Center - Pediatric Outpatient Clinic

    Beer-Sheva, 8410101
    Israel

    Site Not Available

  • Istituto Nazionale dei Tumori

    Milano, Lombardie 20133
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, PI 56124
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

    Milano, 20162
    Italy

    Planned

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Kanazawa University Hospital

    Kanazawa, Ishikawa 920-8641
    Japan

    Site Not Available

  • Osaka City General Hospital

    Miyakojima-Ku, Osaka 534-0021
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Tottori University Hospital

    Yonago, Tottori 683-8504
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Site Not Available

  • Het Nederlands Kanker Instituut - Antoni van Leeuwenhoek

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • University of Auckland

    Auckland, 91346
    New Zealand

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952
    Poland

    Site Not Available

  • Centrum Onkologii Instytut im Marii Curie w Warszawie

    Warszawa, 02-034
    Poland

    Site Not Available

  • National Cancer Centre Singapore

    Singapore, Central Singapore 169610
    Singapore

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 8035
    Spain

    Site Not Available

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Kantonsspital Luzern

    Luzern 16, Luzern 6000
    Switzerland

    Site Not Available

  • Luzerner Kantonsspital

    Spitalstrasse,
    Switzerland

    Site Not Available

  • Cancer Treatment Centers of America

    Goodyear, Arizona 85338
    United States

    Site Not Available

  • Mayo Clinic of Scottsdale

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010-0269
    United States

    Site Not Available

  • University of California - San Diego

    La Jolla, California 92103
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Kaiser Permanente

    Oakland, California 94612
    United States

    Site Not Available

  • Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Kaiser Permanente Medical Center

    Sacramento, California 95814
    United States

    Site Not Available

  • University of California - San Diego

    San Diego, California 92103
    United States

    Site Not Available

  • Kaiser Permanente Medical Center

    San Francisco, California 94115
    United States

    Planned

  • Kaiser Permanente Santa Clara

    San Francisco, California 94115
    United States

    Planned

  • Univ of California San Francisco

    San Francisco, California 94115
    United States

    Site Not Available

  • Kaiser Permanente

    Santa Clara, California 95051
    United States

    Site Not Available

  • Kaiser Permanente Santa Clara

    Santa Clara, California 95051
    United States

    Site Not Available

  • UCLA Medical Center

    Santa Monica, California 90404
    United States

    Site Not Available

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Kaiser Permanente Medical Center

    Vallejo, California 94589
    United States

    Site Not Available

  • Memorial Cancer Institute

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • Tallahassee Memorial Cancer Center

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • University Cancer and Blood Center

    Athens, Georgia 30607
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30329-5102
    United States

    Site Not Available

  • University of Chicago Medicine-Comprehensive Cancer Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Cancer Treatment Centers of America

    Zion, Illinois 60099
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Cancer Treatment Centers of America

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Eastern Regional Medical Center

    Philadelphia, Pennsylvania 19124
    United States

    Site Not Available

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Oncology Consultants

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • University of Wisconsin-Madison Hospital and Health Clinic

    Madison, Wisconsin 53792-4108
    United States

    Site Not Available

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