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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03906331
Expanded Access Status : Available
First Posted : April 8, 2019
Last Update Posted : March 3, 2023
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company ( Loxo Oncology, Inc. )

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Medullary Thyroid Cancer Colon Cancer Breast Cancer Pancreatic Cancer Papillary Thyroid Cancer Other Solid Tumors With Evidence of Activating RET Alteration Drug: Selpercatinib

Detailed Description:
N/A for expanded access
Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Selpercatinib
    Open-label expanded access
    Other Names:
    • LOXO-292
    • LY3527723
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906331


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Loxo Oncology, Inc.
Eli Lilly and Company
Investigators
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Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979) Eli Lilly and Company
More Information
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Responsible Party: Loxo Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03906331    
Other Study ID Numbers: 17494
Selpercatinib EAP ( Other Identifier: Loxo Oncology, Inc. )
J2G-OX-Y001 ( Other Identifier: Eli Lilly and Company )
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: March 2, 2023
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
 Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type