A Phase III Study of Selpercatinib versus Cabozantinib or Vandetanib in Patients with Advanced Medullary Thyroid Cancer

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Full 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) (WIRB)

Purpose

In this study, researchers are comparing the effectiveness of the drug selpercatinib with the standard therapies cabozantinib and vandetanib in patients with advanced medullary thyroid cancer that has mutations in the RET gene. RET mutations lead to uncontrolled cell growth and can fuel cancer growth. Selpercatinib inhibits the altered RET protein.

Patients in this study will be randomly assigned to receive selpercatinib or their physician’s choice of either cabozantinib or vandetanib. Cabozantinib and vandetanib are drugs called tyrosine kinase inhibitors and are already used to treat thyroid cancer. All of these medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced medullary thyroid cancer that continues to grow and contains mutated RET.
  • Patients may not have previously received treatment with a tyrosine kinase inhibitor for advanced disease.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eric Sherman at 646-888-4234.

Protocol

20-008

Phase

III

Investigator

Co-Investigators