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Expanded Access for LOXO-260 in Participants With Cancer Caused by an Abnormal RET Gene That Did Not Respond/is no Longer Responding to Treatment With a Type of Drug Called a RET Inhibitor

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ClinicalTrials.gov Identifier: NCT05225259
Expanded Access Status : Available
First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Collaborator:
Loxo Oncology, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

Expanded access for participants with cancer caused by an abnormal RET gene that did not respond/is no longer responding to treatment with a type of drug called a RET inhibitor.

Participants do not qualify for an ongoing LOXO-260 clinical trial or have other considerations that prevent access to LOXO-260 through an existing clinical trial.

The treating physician/investigator contacts Loxo Oncology, Inc. when, based on their medical opinion, a patient meets the criteria for expanded access.


Condition or disease Intervention/treatment
Carcinoma, Non-Small-Cell Lung Thyroid Neoplasms Drug: LOXO-260

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 of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: LOXO-260
    Oral
    Other Names:
    • LOX-19260
    • LY3838915
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Diagnosis of cancer with RET mutant (medullary thyroid cancer [MTC] or multiple endocrine neoplasia type 2 [MEN2] tumors) or RET fusion (solid tumors) advanced/metastatic tumors that have become refractory to RET selective tyrosine kinase inhibitor (TKI) treatment, who are not eligible or able to participate in an ongoing LOXO-260 clinical trial and are medically suitable for treatment with LOXO-260.
  • 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 LOXO-260 or another second generation 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
  • Clinically significant malabsorption syndrome
  • Pregnant or lactating
  • Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4
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): NCT05225259


Contacts
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Contact: Patient Advocacy 1-855-LOXO-305 clinicaltrials@loxooncology.com

Sponsors and Collaborators
Eli Lilly and Company
Loxo Oncology, Inc.
Investigators
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Study Director: Emin Avsar, MD Loxo Oncology, Inc.
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05225259    
Other Study ID Numbers: LOXO-260 Expanded Access
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: January 2022
Keywords provided by Eli Lilly and Company:
Solid tumors
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases