Clinical Trials List
Protocol NumberJ2G-MC-JZJB
NCT Number(ClinicalTrials.gov Identfier)NCT04211337
Active
2020-12-11 - 2027-11-13
Phase III
Recruiting3
ICD-9V10.87
Personal history of malignant neoplasm of thyroid
A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly and Company
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 洪崇傑 Division of General Surgery
- 楊舜如 Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Li-Yuan Bai Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jih-Hsiang Lee Division of Hematology & Oncology
- 施翔蓉 Division of Endocrinology
- 呂金盈 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Medullary Thyroid Cancer
Objectives
The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
Test Drug
Selpercatinib (LY3527723)
Active Ingredient
Selpercatinib (LY3527723)
Dosage Form
capsule
Dosage
40/80
Endpoints
Primary
To compare TFFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with selpercatinib versus cabozantinib or vandetanib.
Secondary
To compare other efficacy outcomes, based on RECIST 1.1 criteria, observed in patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with selpercatinib versus cabozantinib or vandetanib.
To evaluate the safety and tolerability of selpercatinib compared to cabozantinib or vandetanib.
To compare the tolerability of selpercatinib versus cabozantinib or vandetanib
To assess/evaluate performance of local RET laboratory tests compared to a single, central test.
To assess the PK of selpercatinib in patients receiving selpercatinib.
To compare TFFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with selpercatinib versus cabozantinib or vandetanib.
Secondary
To compare other efficacy outcomes, based on RECIST 1.1 criteria, observed in patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with selpercatinib versus cabozantinib or vandetanib.
To evaluate the safety and tolerability of selpercatinib compared to cabozantinib or vandetanib.
To compare the tolerability of selpercatinib versus cabozantinib or vandetanib
To assess/evaluate performance of local RET laboratory tests compared to a single, central test.
To assess the PK of selpercatinib in patients receiving selpercatinib.
Inclution Criteria
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.
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.
Exclusion Criteria
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.
Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months, history of Torsades de pointes, or prolongation of the QTcF >470 milliseconds on more than one electrocardiogram (ECG) during screening. Participants who are intended to receive vandetanib if randomized to the control arm ineligible if QTcF is >450 milliseconds.
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.
Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months, history of Torsades de pointes, or prolongation of the QTcF >470 milliseconds on more than one electrocardiogram (ECG) during screening. Participants who are intended to receive vandetanib if randomized to the control arm ineligible if QTcF is >450 milliseconds.
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.
The Estimated Number of Participants
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Taiwan
8 participants
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Global
400 participants
