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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 : January 18, 2023
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company ( Loxo Oncology, Inc. )

Tracking Information
First Submitted Date April 4, 2019
First Posted Date April 8, 2019
Last Update Posted Date January 18, 2023
 
Descriptive Information
Brief Title Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Official Title Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
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.

Detailed Description N/A for expanded access
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition
  • 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
Intervention Drug: Selpercatinib
Open-label expanded access
Other Names:
  • LOXO-292
  • LY3527723
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contacts
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
Listed Location Countries Australia,   France,   Germany,   Hong Kong,   Israel,   Italy,   Japan,   New Zealand,   Poland,   Singapore,   Spain,   Switzerland,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number NCT03906331
Other Study ID Numbers 17494
Selpercatinib EAP ( Other Identifier: Loxo Oncology, Inc. )
J2G-OX-Y001 ( Other Identifier: Eli Lilly and Company )
Current Responsible Party Eli Lilly and Company ( Loxo Oncology, Inc. )
Original Responsible Party Same as current
Current Study Sponsor Loxo Oncology, Inc.
Original Study Sponsor Same as current
Collaborators Eli Lilly and Company
Investigators
Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date January 15, 2023