Official Title
Expanded Access of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment
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.

Available
Individual Patients
Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms

Drug: LOXO-260

Oral
Other Name: LY3838915

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

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Contacts

Patient Advocacy
1-855-569-6305
clinicaltrials@loxooncology.com

Emin Avsar, MD, Study Director
Loxo Oncology, Inc.

Loxo Oncology, Inc.
NCT Number
Keywords
solid tumors
MeSH Terms
Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms