Carcinoma, Non-Small-Cell LungNCT05225259
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
A study testing LOXO-260 in people with Carcinoma, Non-Small-Cell Lung and Thyroid Neoplasms, run by Eli Lilly and Company.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms
- What is being tested?
- LOXO-260
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Expanded Access of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms
- Being tested
- LOXO-260
- Keywords
- Solid tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOXO-260Drug
Also called LY3838915
Oral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Emin Avsar, MD, Study director, Loxo Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225259
- Sponsor's protocol ID
- LOXO-260 Expanded Access
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment
- ClinicalTrials.gov ID
- NCT05225259
- Acronym / sponsor ID
- LOXO-260 Expanded Access
- Conditions
- Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms
- Keywords
- Solid tumors
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Loxo Oncology, Inc.
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOXO-260Also: LY3838915Oral | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emin Avsar, MD study director
Loxo Oncology, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing LOXO-260 in people with Carcinoma, Non-Small-Cell Lung and Thyroid Neoplasms, run by Eli Lilly and Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.