Study on Selpercatinib and Radioactive Iodine for Treating RET Fusion-Positive Thyroid Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05668962

Provider View

This clinical trial is testing whether the drug selpercatinib can help restore the effectiveness of radioactive iodine treatment in patients with a specific type of thyroid cancer that does not respond to standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug selpercatinib can help make radioactive iodine (I-131) treatment work again in people with a type of thyroid cancer that has a RET gene fusion and does not respond to radioiodine. The study involves using selpercatinib along with standard treatments, including I-131 and a hormone called thyrotropin alfa (rhTSH).

Description

This study involves several steps, including checking if participants are eligible, providing the study treatment, and having follow-up visits. Participants will receive selpercatinib along with standard treatments like I-131 and rhTSH. The treatment will continue for about a month, up to two courses, as long as the cancer does not get worse and there are no severe side effects. Participants will be monitored for two years after joining the study.

About 30 people are expected to participate in this Phase II clinical trial. Phase II trials test the safety and effectiveness of a new treatment to see if it works for a specific disease. Although selpercatinib, I-131, and rhTSH are approved for treating thyroid cancer, their combination in this study is still being investigated.

Selpercatinib is designed to block a specific cancer signal, and it is used along with I-131 and rhTSH, which are standard treatments for thyroid cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of a specific type of thyroid cancer that has spread or cannot be removed by surgery and has a RET gene fusion.
  • Must be 18 years or older, or between 12 and 18 years old with certain conditions.
  • Must have cancer that has grown within 18 months before joining the study.
  • Must have cancer that does not respond to radioactive iodine treatment.
  • Must have no single tumor larger than 4 cm.
  • Must have received no more than a certain amount of radioactive iodine treatment.
  • Must have mild or no symptoms from the cancer.
  • Must have had no more than one previous treatment for this type of thyroid cancer.
  • Must have good organ function and be able to swallow medications.
  • Must not have any serious infections or other medical conditions that would prevent safe participation.
  • Must agree to use effective birth control during and after the study.
  • Must not be pregnant or breastfeeding.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have had certain cancer treatments within the last 4 weeks.
  • Cannot have had radioactive iodine treatment within the last 12 months.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot be taking other experimental drugs.
  • Cannot have active or untreated brain cancer.
  • Cannot have serious heart problems or certain heart test results.
  • Cannot have uncontrolled high blood pressure.
  • Cannot have serious infections or other uncontrolled medical conditions.
  • Cannot have uncontrolled thyroid problems.
  • Cannot have active bleeding or be at high risk for bleeding.
  • Cannot be taking medications that affect heart rhythm.

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