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

January 16, 2025 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

N/A for expanded access

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • NSW Health - Sydney Local Health District
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Queensland Health - Metro North Hospital and Health Service
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research
  • France
      • Marseille, France, 13005
        • AP-HM
      • Villejuif, France, 94805
        • Gustave Roussy
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Universitätsklinikum Würzburg A. ö. R.
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Universitatsklinikum Koln
  • Hong Kong
    • Shatin, New Territories
      • Hong Kong, Shatin, New Territories, Hong Kong, 999077
        • Prince of Wales Hospital
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center - Pediatric Outpatient Clinic
    • Central District
      • Ramat Gan, Central District, Israel, 5262100
        • Sheba Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Istituto Nazionale dei Tumori
    • PI
      • Pisa, PI, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana
  • Japan
      • Osaka, Japan, 534-0021
        • Osaka City General Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
        • Tottori University Hospital
  • New Zealand
      • Auckland, New Zealand, 91346
        • University of Auckland
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Warsaw, Poland, 02-034
        • Centrum Onkologii Instytut im Marii Curie w Warszawie
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169610
        • National Cancer Centre Singapore
  • Spain
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 8035
        • Hospital Universitari Vall d'Hebron
  • Switzerland
    • Canton of Lucerne
      • Lucerne, Canton of Lucerne, Switzerland, 6000
        • Kantonsspital Luzern
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Cancer Treatment Centers of America
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic of Scottsdale
    • California
      • Duarte, California, United States, 91010-0269
        • City of Hope National Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Oakland, California, United States, 94612
        • Kaiser Permanente
      • Orange, California, United States, 92868
        • Irvine Medical Center
      • San Diego, California, United States, 92103
        • University of California - San Diego
      • San Francisco, California, United States, 94115
        • Univ of California San Francisco
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
      • Orlando, Florida, United States, 32803
        • Florida Hospital
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Cancer Center
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer and Blood Center
      • Atlanta, Georgia, United States, 30329-5102
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine-Comprehensive Cancer Center
      • Zion, Illinois, United States, 60099
        • Cancer Treatment Centers of America
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Grand Rapids, Michigan, United States, 49546
        • START Midwest
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Cancer Treatment Centers of America
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19124
        • Eastern Regional Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Oncology Consultants
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-4108
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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