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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. Identifier: NCT03906331
Expanded Access Status : Available
First Posted : April 8, 2019
Last Update Posted : February 7, 2020
Eli Lilly and Company
Information provided by (Responsible Party):
Loxo Oncology, Inc.

Tracking Information
First Submitted Date April 4, 2019
First Posted Date April 8, 2019
Last Update Posted Date February 7, 2020
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 patients 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.
Detailed Description N/A for expanded access
Study Type Expanded Access
Expanded Access Type Individual Patients, Treatment IND/Protocol
  • 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 Name: LOXO-292
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by 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

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study of selpercatinib or another RET inhibitor
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Contact: Patient Advocacy 888-406-9574
Contact: Patient Advocacy 855-RET-4-292 (855-738-4292)
Listed Location Countries Australia,   Singapore,   Spain,   United States
Removed Location Countries  
Administrative Information
NCT Number NCT03906331
Other Study ID Numbers Selpercatinib EAP
Selpercatinib EAP ( Other Identifier: Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company )
Responsible Party Loxo Oncology, Inc.
Study Sponsor Loxo Oncology, Inc.
Collaborators Eli Lilly and Company
Study Director: Jen Kherani, MD Loxo Oncology
PRS Account Loxo Oncology, Inc.
Verification Date October 2019