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
About this trial
This is an expanded access trial for Carcinoma, Non-Small-Cell Lung focused on measuring Solid tumors
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.
- 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
NCT ID
NCT05225259
First Posted
January 28, 2022
Last Updated
August 16, 2023
Sponsor
Eli Lilly and Company
Collaborators
Loxo Oncology, Inc.
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
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Primary Completion Date
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Study Completion Date
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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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