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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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Available
CT.gov ID
NCT05225259
Collaborator
Loxo Oncology, Inc. (Industry)

Study Details

Study Description

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 Phase

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Loxo Oncology, Inc.

    Investigators

    • Study Director: Emin Avsar, MD, Loxo Oncology, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05225259
    Other Study ID Numbers:
    • LOXO-260 Expanded Access
    First Posted:
    Feb 4, 2022
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Jan 1, 2022
    Keywords provided by Eli Lilly and Company
    Solid tumors
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Thyroid Neoplasms

    Study Results

    No Results Posted as of Feb 4, 2022