Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Loxo Oncology, Inc.
With
Eli Lilly and Company
Adaptive sample size re-estimation will be performed at interim analysis. The sample size could be increased from approximately 250 to 400 depending on the results of interim analysis.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 18 years of age (participants as young as 12 years of age will be allowed if permitted by local regulatory authorities).
Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease.
Radiographic progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at screening compared with a previous image taken within the prior 14 months as assessed by the BICR. Participants with measurable or non-measurable but evaluable disease are eligible; however, participants with non-measurable disease may not have disease limited to bone sites only.
A defined/acceptable RET gene alteration identified in a tumor, germline deoxyribonucleic acid (DNA) or blood sample.
* Tumor tissue in sufficient quantity to allow for retrospective central analysis of RET mutation status
Eastern Cooperative Oncology Group performance status score of 0 to 2.
Adequate hematologic, hepatic, and renal function and electrolytes.
Men and women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 4 months following the last dose of study drug.
Ability to swallow capsules.
Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing uncontrolled intercurrent illness.
Active hemorrhage or at significant risk for hemorrhage.
Other malignancy unless nonmelanoma skin cancer, carcinoma in situ or malignancy diagnosed ≥2 years previously and not currently active. Participants with multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be eligible.
You may not be if
An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS or BRAF gene mutations and NTRK gene fusions.
Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
Clareo Health | A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
