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Tyrosine Kinase Inhibitor

Selpercatinib Before Surgery for Thyroid Cancer

Phase 2

Waitlist Available

Led By Mark Zafereo

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

At least 12 years of age on the day of signing informed consent

Patients with RET-altered thyroid cancer who present with locally advanced primary tumor, defined as T3 or T4 by imaging or invasive/bulky nodal disease, or with recurrent/residual invasive/bulky nodal disease will be enrolled in this trial, regardless of whether distant metastases are present or not

Must not have

Uncontrolled symptomatic hypercalcemia or hypocalcemia

Active uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing intercurrent illness, such as uncontrolled hypertension (systolic blood pressure [BP] >= 140 mmHg or diastolic BP >= 90 mmHg per CTCAE) or diabetes, despite optimal treatment. Screening for chronic conditions is not required

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations.

Who is the study for?

This trial is for patients with thyroid cancer showing RET gene changes, aged 12 or older, who can handle outpatient treatment and surgery. They must have a measurable tumor lesion and not have been treated with certain other RET inhibitors. Patients should be able to take contraceptives if of childbearing potential.

What is being tested?

The study tests the effects of Selpercatinib given before surgery on thyroid cancer patients with genetic alterations in the RET gene. The goal is to see if it can shrink tumors and control disease progression prior to surgical intervention.

What are the potential side effects?

Selpercatinib may cause liver enzyme elevation, high blood pressure, dry mouth, diarrhea, increased risk of bleeding or heart rhythm problems (QT prolongation), fatigue, rash, constipation, muscle pain and possibly affect wound healing post-surgery.

Eligibility Criteria

Inclusion Criteria

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

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I am at least 12 years old.

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My thyroid cancer is advanced or has come back, and it may have spread.

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My surgery is considered to have a moderate to unresectable complexity level.

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My cancer has a specific genetic change called RET alteration.

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My thyroid cancer diagnosis fits one of the specified types.

Exclusion Criteria

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

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I have uncontrolled high or low calcium levels causing symptoms.

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I do not have any uncontrolled infections or serious illnesses like high blood pressure or diabetes.

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

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I have symptoms from a brain tumor, brain metastases, cancer in my spinal fluid, or untreated spinal cord compression.

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I have a condition that affects how my body absorbs medication.

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I haven't taken any cancer treatment within the last 3 weeks or 5 half-lives, whichever is shorter.

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I have been treated with a specific medication for cancer targeting the RET gene.

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I haven't had a heart attack or serious heart issues in the last 6 months.

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My thyroid condition is not under control and causes symptoms.

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I haven't had major surgery in the last 4 weeks.

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I have another cancer besides the one being studied, but it's slow-growing and not being actively treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment 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 (ORR)

Tumor response

Secondary study objectives

Incidence of adverse events

Locoregional PFS

Overall survival (OS)

+5 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: Treatment (selpercatinib)Experimental Treatment4 Interventions

Patients receive selpercatinb PO BID on days 1-28. Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selpercatinib

2021

Completed Phase 1

~600

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9890