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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 : October 4, 2019
Sponsor:
Collaborator:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03906331


Contacts
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Contact: Patient Advocacy 888-406-9574 LoxoNPP@UBC.com
Contact: Patient Advocacy 855-RET-4-292 (855-738-4292) clinicaltrials@loxooncology.com

Locations
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United States, Florida
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Contact: Luis Raez, MD         
Principal Investigator: Luis Raez, MD         
AdventHealth Orlando
Orlando, Florida, United States, 32804
Contact: Mark Socinski, MD         
Principal Investigator: Mark Socinski, MD         
United States, Georgia
University Cancer and Blood Center
Athens, Georgia, United States, 30607
Contact: Petros Nikolinakos, MD         
Principal Investigator: Petros Nikolinakos, 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, 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, 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         
Sponsors and Collaborators
Loxo Oncology, Inc.
Eli Lilly and Company
Investigators
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Study Director: Jen Kherani, MD Loxo Oncology

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Responsible Party: Loxo Oncology, Inc.
ClinicalTrials.gov 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: October 4, 2019
Last Verified: October 2019
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