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

September 29, 2023 updated by: Loxo Oncology, Inc.

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

N/A for expanded access

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Available
        • NSW Health - Sydney Local Health District
      • St. Leonards, New South Wales, Australia, 2065
        • Available
        • Royal North Shore Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Available
        • Queensland Health - Metro North Hospital and Health Service
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Available
        • Linear Clinical Research
  • France
      • Marseille, France, 13005
        • Available
        • AP-HM
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Available
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
  • Germany
      • Berlin, Germany, 13353
        • Available
        • Charité Campus Virchow-Klinikum
    • Bayern
      • Würzburg, Bayern, Germany, 97080
        • Available
        • Universitätsklinikum Würzburg A. ö. R.
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Available
        • Universitatsklinikum Koln
  • Israel
      • Beer-Sheva, Israel, 8410101
        • Available
        • Soroka Medical Center - Pediatric Outpatient Clinic
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 9103102
        • Available
        • Shaare Zedek Medical Center
  • Italy
      • Milano, Italy, 20162
        • Available
        • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
    • Lombardie
      • Milano, Lombardie, Italy, 20133
        • Available
        • Istituto Nazionale dei Tumori
    • PI
      • Pisa, PI, Italy, 56124
        • Available
        • Azienda Ospedaliero Universitaria Pisana
  • Japan
      • Osaka, Japan, 534-0021
        • Available
        • Osaka City General Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Available
        • National Cancer Center Hospital East
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Available
        • Hokkaido University Hospital
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Available
        • Kanazawa University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Available
        • National Cancer Center Hospital
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
        • Available
        • Tottori University Hospital
  • New Zealand
      • Auckland, New Zealand, 91346
        • Available
        • University of Auckland
  • Poland
      • Warszawa, Poland, 02-034
        • Available
        • Centrum Onkologii Instytut im Marii Curie w Warszawie
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169610
        • Available
        • National Cancer Centre Singapore
  • Spain
      • Madrid, Spain, 28050
        • Available
        • Hospital Madrid Norte Sanchinarro
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 8035
        • Available
        • Hospital Universitari Vall d'Hebron
  • Switzerland
    • Luzern
      • Luzern 16, Luzern, Switzerland, 6000
        • Available
        • Kantonsspital Luzern
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Available
        • Cancer Treatment Centers of America
      • Scottsdale, Arizona, United States, 85259
        • Available
        • Mayo Clinic of Scottsdale
    • California
      • Duarte, California, United States, 91010-0269
        • Available
        • City of Hope National Medical Center
      • Orange, California, United States, 92868
        • Available
        • Irvine Medical Center
      • San Diego, California, United States, 92103
        • Available
        • University of California - San Diego
      • San Francisco, California, United States, 94115
        • Available
        • Univ of California San Francisco
    • Florida
      • Hollywood, Florida, United States, 33021
        • Available
        • Memorial Cancer Institute
      • Jacksonville, Florida, United States, 32224
        • Available
        • Mayo Clinic in Florida
      • Orlando, Florida, United States, 32803
        • Available
        • Florida Hospital
      • Tallahassee, Florida, United States, 32308
        • Available
        • Tallahassee Memorial Cancer Center
    • Georgia
      • Athens, Georgia, United States, 30607
        • Available
        • University Cancer and Blood Center
      • Atlanta, Georgia, United States, 30329-5102
        • Available
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Available
        • University of Chicago Medicine-Comprehensive Cancer Center
      • Zion, Illinois, United States, 60099
        • Available
        • Cancer Treatment Centers of America
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Available
        • University of Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Available
        • START Midwest
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Available
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10065
        • Available
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Available
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Available
        • Ohio State University Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Available
        • Cancer Treatment Centers of America
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • University of Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19124
        • Available
        • Eastern Regional Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Available
        • Virginia Cancer Specialists
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-4108
        • Available
        • University of Wisconsin-Madison Hospital and Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loxo Oncology, Inc.

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 15, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17494
  • Selpercatinib EAP (Other Identifier: Loxo Oncology, Inc.)
  • J2G-OX-Y001 (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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