NCT04211337

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Loxo Oncology, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Medullary Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Selpercatinib	Administered orally
DRUG	Cabozantinib	Administered orally
DRUG	Vandetanib	Administered orally

Timeline

• Start date: 2020-02-11
• Primary completion: 2023-05-22
• Completion: 2027-11-01
• First posted: 2019-12-26
• Last updated: 2026-03-19
• Results posted: 2024-06-13

Locations

143 sites across 20 countries: United States, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study