Selpercatinib Before Surgery for Treating RET-Altered Thyroid Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04759911

Provider View

This study is testing if the drug selpercatinib, given before surgery, can help shrink thyroid tumors with RET gene changes. The goal is to see if this approach can better control the cancer and make surgery more effective.

Patient Parameters

Program Overview

This phase II study is exploring the effects of selpercatinib, a drug that may block enzymes needed for tumor growth, in patients with thyroid cancer that has RET gene changes. By taking selpercatinib before surgery, researchers hope to shrink the tumors and improve disease control.

Description

The main goal of this study is to see how well selpercatinib works in shrinking medullary thyroid cancer tumors before surgery, using a standard measurement called the objective response rate (ORR). Researchers will also look at how the drug affects surgical outcomes, safety, and how long patients stay free from cancer progression.

Secondary goals include assessing the drug's impact on surgical margins (how much cancer is left after surgery), safety, and progression-free survival (PFS). The study will also explore patient-reported outcomes and quality of life, as well as collect tissue samples to understand how the drug works and why it might stop working.

Participants will take selpercatinib by mouth twice a day for up to 7 cycles, each lasting 28 days, unless the cancer progresses or side effects become too severe. After completing the treatment, patients will have surgery as part of their standard care. Follow-up visits will occur every 3-4 months for the first 2 years, and less frequently in the following years for some patients.

Eligibility Criteria

Inclusion Criteria

  • Have RET-altered thyroid cancer with advanced or recurrent disease.
  • Be at least 12 years old.
  • Have a confirmed diagnosis of certain types of thyroid cancer, including medullary, papillary, poorly differentiated, or anaplastic thyroid cancer.
  • Have a RET gene change confirmed by a certified lab test.
  • Previous treatment with certain drugs is allowed, but not with selective RET inhibitors.
  • Have at least one measurable tumor.
  • Be in good enough health to undergo surgery if the tumor becomes operable.
  • Meet specific blood and organ function criteria.
  • Be willing to provide a tumor biopsy and follow study procedures.
  • Agree to use effective birth control during and after the study if of childbearing potential.

Exclusion Criteria

  • Have another known genetic change that could affect treatment.
  • Have taken selective RET inhibitors before.
  • Have had recent major surgery or other cancer treatments.
  • Have unresolved side effects from previous treatments.
  • Have active or untreated brain or spinal cord tumors.
  • Have significant heart problems or other serious health conditions.
  • Be pregnant or breastfeeding.
  • Have another active cancer, with some exceptions.

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