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.
Drug: LOXO-260
Oral
Other Name: LOX-19260
Other Name: LY3838915
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
Emin Avsar, MD
Study Director
Loxo Oncology, Inc.