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

Titre officiel

A Multicentre, 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)

Sommaire:

Cette étude vise à déterminer si le médicament à l’étude, le selpercatinib, est sûr et plus efficace qu’un traitement standard chez les participants atteints d’un cancer médullaire de la thyroïde (CMT) à mutation RET qui ne peut être retiré au moyen d’une intervention chirurgicale ou qui s’est propagé à d’autres parties du corps. Les participants qui se voient attribuer le traitement standard et qui l’interrompent à la suite d’une progression de la maladie ont la possibilité de passer au selpercatinib.

Description de l'essai

Primary Outcome:

• Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)

• Progression Free Survival (PFS) by BICR
• Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR
• Duration of Response (DoR) by BICR
• Overall Survival (OS)
• PFS2 by Investigator
• Comparative Tolerability: Percentage of Time with High Side Effect Bother Based on the Functional Assessment of Cancer Therapy-Side Effects (FACT-GP5)
• The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)

Voir cet essai sur ClinicalTrials.gov