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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 : November 25, 2019
Eli Lilly and Company
Information provided by (Responsible Party):
Loxo Oncology, Inc.

Brief Summary:
Expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.

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: LOXO-292

Detailed Description:
N/A for expanded access

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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Treatment IND/Protocol
  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

Intervention Details:
  • Drug: LOXO-292
    Open-label expanded access

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Diagnosis of cancer with RET activation, who are not eligible for an ongoing LOXO-292 clinical trial and are medically suitable for treatment with LOXO-292

Exclusion Criteria:

  • Currently enrolled in an ongoing clinical study of LOXO-292 or another RET inhibitor

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 identifier (NCT number): NCT03906331

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Contact: Patient Advocacy 888-406-9574
Contact: Patient Advocacy 855-RET-4-292 (855-738-4292)

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United States, Arizona
Mayo Clinic Hospital
Scottsdale, Arizona, United States, 85054
Contact: Nina Karlin         
Principal Investigator: Nina Karlin, MD         
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Contact: Alain Algazi, MD         
Principal Investigator: Alain Algazi, MD         
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States, 90502
Contact: Mykola Onyshchenko, MD         
Principal Investigator: Mykola Onshchenko, MD         
United States, Florida
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Contact: Luis Raez, MD         
Principal Investigator: Luis Raez, MD         
Mayo Clinic Hospital
Jacksonville, Florida, United States, 32224
Contact: Victor Bernet, MD         
Principal Investigator: Victor Bernet, MD         
AdventHealth Orlando
Orlando, Florida, United States, 32804
Contact: Mark Socinski, MD         
Principal Investigator: Mark Socinski, MD         
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
Contact: Karen Russell, MD         
Principal Investigator: Karen Russell, MD         
United States, Georgia
University Cancer and Blood Center
Athens, Georgia, United States, 30607
Contact: Petros Nikolinakos, MD         
Principal Investigator: Petros Nikolinakos, MD         
Emory University
Atlanta, Georgia, United States, 30322
Contact: Taofeek Owonikoko, MD         
Principal Investigator: Taofeek Owonikoko, MD         
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Lori Wirth, MD         
Principal Investigator: Lori Wirth, MD         
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact: Geoffrey Oxnard, MD         
Sub-Investigator: Geoffrey Oxnard, MD         
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Francis Worden, MD         
Principal Investigator: Francis Worden, MD         
START Midwest
Grand Rapids, Michigan, United States, 49546
Contact: Nehal Lakhani, MD         
Principal Investigator: Nehal Lakhani, MD         
United States, Minnesota
Mayo Clinic Hospital
Rochester, Minnesota, United States, 55905
Contact: John Morris, MD         
Principal Investigator: John Morris, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Contact: Fadi Braiteh, MD         
Principal Investigator: Fadi Braiteh, MD         
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: Alexander Drilon, MD         
Principal Investigator: Alexander Drilon, MD         
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Nathan Pennell, MD         
Principal Investigator: Nathan Pennell, MD         
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Vivek Subbiah, MD         
Principal Investigator: Vivek Subbiah, MD         
Oncology Consultants
Houston, Texas, United States, 77030
Contact: Julio Peguero, MD         
Principal Investigator: Julio Peguero, MD         
United States, Virginia
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Contact: Alexander Spira, MD         
Principal Investigator: Alexander Spira, MD         
Australia, Western Australia
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Contact: Samantha Bowyer, MD         
Principal Investigator: Samantha Bowyer, MD         
START Madrid, Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Contact: Valentina Boni, MD         
Principal Investigator: Valentina Boni, MD         
Sponsors and Collaborators
Loxo Oncology, Inc.
Eli Lilly and Company
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Study Director: Jen Kherani, MD Loxo Oncology

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Responsible Party: Loxo Oncology, Inc. Identifier: NCT03906331     History of Changes
Other Study ID Numbers: LOXO-292 EAP
LOXO-292 EAP ( Other Identifier: Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company )
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type