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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate

Secondary outcome measures

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

Overall Response Rate-Adolescent

Overall Survival

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SELPERCATINIB + I-131Experimental 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. Those participants in whom radioiodine uptake has been restored may be offered a second 4-week course of selpercatinib plus I-131 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

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,931 Previous Clinical Trials

13,198,415 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,618 Previous Clinical Trials

3,201,530 Total Patients Enrolled

Lori J. Wirth, MDPrincipal InvestigatorMassachusetts General Hospital

3 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Selpercatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05668962 — Phase 2

Thyroid Cancer Clinical Trial 2023: Selpercatinib Highlights & Side Effects. Trial Name: NCT05668962 — Phase 2

Thyroid Cancer Research Study Groups: SELPERCATINIB + I-131

Selpercatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05668962 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still taking on participants?

"Clinicaltrials.gov indicates that this particular study is no longer actively recruiting participants, with recruitment starting on the 1st of January 2023 and concluding on December 20th 2022. However, there are currently 2560 trials seeking new patients to enroll in them."

Answered by AI

Does the FDA recognize SELPERCATINIB + I-131 as a viable therapeutic option?

"Our experts at Power rated the safety of SELPERCATINIB + I-131 as a 2 due to its Phase 2 designation. This means that there is some evidence suggesting it may be safe, but no data demonstrating efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC

Lori J. Wirth, MD 2023. "Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05668962.

All > Medullary Thyroid Cancer