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Tyrosine Kinase Inhibitor

Selpercatinib + I-131 for Thyroid Cancer

Phase 2

Recruiting

Led By Lori J. Wirth, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have RAI-refractory disease

Participants ≥ 16 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Must not have

Participants with symptomatic hypercalcemia or hypocalcemia

Participants with uncontrolled symptomatic hyperthyroidism or hypothyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug to see if it can help people with a certain type of thyroid cancer get the most from I-131 treatments.

Who is the study for?

Adults and children (12+) with certain types of advanced thyroid cancer that have a specific gene change called RET fusion. They must be able to swallow pills, not have had recent major treatments or surgeries, and should not be pregnant or breastfeeding. People with controlled HIV or hepatitis are eligible, but those with serious heart conditions, uncontrolled infections, or other severe illnesses cannot join.

What is being tested?

The trial is testing if the drug selpercatinib can make thyroid cancers that no longer respond to radioactive iodine treatment start responding again. Participants will receive selpercatinib along with standard treatments including I-131 and rhTSH injections.

What are the potential side effects?

Selpercatinib may cause liver problems, high blood pressure, bleeding issues, heart rhythm changes (QT prolongation), allergic reactions, and could affect fertility in both men and women. The full range of side effects is still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My thyroid cancer does not respond to radioactive iodine treatment.

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I am 16 or older and can do all my daily activities without help.

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My hepatitis B is under control with treatment.

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My largest tumor is smaller than 4.0 cm.

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My thyroid cancer is advanced, cannot be surgically removed, and has a specific genetic change.

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I had hepatitis C but have been treated and cured.

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My organs and bone marrow are functioning well.

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I am 18 years old or older.

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It has been over 28 days since my last major surgery or radiation treatment.

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I can swallow pills and don't have stomach issues affecting medicine absorption.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have high or low calcium levels causing symptoms.

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My thyroid condition is not under control and causes symptoms.

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I do not have brain metastases causing symptoms or at risk of spinal cord compression.

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I am taking medication that can affect my heart's rhythm.

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I am currently experiencing significant bleeding or at high risk for serious bleeding.

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I do not have serious heart disease or a history of specific abnormal heart rhythms.

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I have received I-131 treatment in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate

Secondary study objectives

Number of Participants with Treatment Related Adverse Events as Assessed CTCAE v5.0

Overall Response Rate-Adolescent

Overall Survival

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SELPERCATINIB + I-131 NaIExperimental Treatment3 Interventions

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Participants will be treated with Selpercatinib for 4 weeks. * In the fourth week of treatment, participants will receive a therapeutic dose of I-131 NaI. * Those participants in whom radioiodine uptake has been restored may be offered a second 4-week course of selpercatinib plus I-131 NaI treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rhTSH

2008

Completed Phase 4

~270

Selpercatinib

2021

Completed Phase 1

~600