CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 291 enrolled
Drug / intervention
Selpercatinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04211337
NCT04211337Phase 3Active

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)

Loxo Oncology, Inc.·interventional·Posted Dec 26, 2019·Updated Mar 19, 2026

In Brief

A Phase 3 clinical trial evaluating Selpercatinib, Cabozantinib, and 1 other intervention for Medullary Thyroid Cancer. Active but no longer recruiting, targeting 291 participants across 143 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom, United States

Timeline

Phase 3Active
202020212022202320242025202620272028
First PostedDec 26, 2019
Enrollment StartFeb 11, 2020
Primary CompletionMay 22, 2023
Study CompletionNov 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.5 years ago

Interventions

Selpercatinibdrug

Administered orally

Cabozantinibdrug

Administered orally

Vandetanibdrug

Administered orally