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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

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
LOXO-260
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Carcinoma, Non-Small-Cell Lung focused on measuring Solid tumors

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 28, 2022
    Last Updated
    August 16, 2023
    Sponsor
    Eli Lilly and Company
    Collaborators
    Loxo Oncology, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05225259
    Brief Title
    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
    Official Title
    Expanded Access of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eli Lilly and Company
    Collaborators
    Loxo Oncology, Inc.

    4. Oversight

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms
    Keywords
    Solid tumors

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    LOXO-260
    Other Intervention Name(s)
    LY3838915
    Intervention Description
    Oral

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Eligibility 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. Patients tumor must have developed RET solvent front mutations (eg G810X) after RET selective treatment. 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 Patients must reside in a country where the LOXO-NGR-21001 study (NCT05241834) is not open or recruiting. 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 Patients harboring known activating bypass alterations outside RET (eg. EGFR, ALK, RAS etc) that may confer resistance to LOXO-260
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patient Advocacy
    Phone
    1-855-569-6305
    Email
    clinicaltrials@loxooncology.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emin Avsar, MD
    Organizational Affiliation
    Loxo Oncology, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    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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