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Clinical trial

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

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Last updated:17th Jun 2021
Status: Recruiting
Identifier: NCT04211337
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

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.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date: February 11, 2020
Estimated Primary Completion Date: May 20, 2024
Estimated Study Completion Date: November 13, 2026

- Experimental: Selpercatinib
- Active Comparator: Cabozantinib or Vandetanib

Category Value
Study type(s) Interventional
Estimated enrolment 400
Actual Study start date 11 February 2020
Estimated Study Completion Date 13 November 2026

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