Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT05225259
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
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05225259
Study Brief:
Protocol Section:
NCT05225259