Selpercatinib Before Surgery for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Mark Zafereo

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations (changes in the genetic material \[deoxyribonucleic acid (DNA)\]). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving selpercatinib before surgery may help shrink the tumors and help control the disease.

Eligibility Criteria

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.

Inclusion Criteria

I can care for myself and remain up and about more than half of my waking hours.

Your hemoglobin level is at least 9 grams per deciliter.

Your platelet count is at least 100,000 per microliter.

Exclusion Criteria

I have uncontrolled high or low calcium levels causing symptoms.

You had a very strong allergic reaction (grade 3 or higher) to selpercatinib or any of its ingredients.

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

Participant Groups

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.

Group I: Treatment (selpercatinib) Experimental Treatment 4 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.

Selpercatinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as RETEVMO for:

• RET fusion-positive or RET mutant thyroid cancers
• non-small cell lung cancer
• advanced or metastatic medullary thyroid cancer
• advanced or metastatic thyroid cancer with RET gene fusion
• locally advanced or metastatic solid tumors with RET gene fusion

🇪🇺 Approved in European Union as RETEVMO for:

• RET-driven non-small cell lung cancer
• medullary thyroid cancer
• thyroid cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, MD

M D Anderson Cancer Center Houston, TX

University of Michigan Health Systems Ann Arbor, MI

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References