Actively Recruiting
Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery
Led by M.D. Anderson Cancer Center · Updated on 2026-04-24
45
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
To look at the effectiveness of zanzalintinib, followed by surgery, in treating advanced thyroid cancer. The safety of this treatment will also be studied.
CONDITIONS
Official Title
Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older who sign informed consent
- Diagnosis of differentiated thyroid cancer, non-RET-mutated medullary thyroid cancer, or poorly differentiated thyroid cancer with locally advanced or recurrent invasive disease
- Pathologic confirmation of papillary, follicular, oncocytic, medullary, or poorly differentiated thyroid carcinoma
- Surgical morbidity or complexity score between 1 and 4 (moderate to unresectable)
- ECOG performance status of 0 to 2 with no recent sudden deterioration
- Recovery to baseline or Grade 1 or less severity from prior treatment-related adverse events, with some low-grade toxicities allowed
- Adequate organ and marrow function based on specific laboratory tests within 28 days before treatment
- Ability to understand and comply with study protocol
- Willingness to undergo tumor biopsy (at MD Anderson site) and surgery if tumor becomes operable
- Agreement to use effective contraception during and after the study as specified
- Female participants of childbearing potential must have a negative pregnancy test and meet menopause or sterilization criteria
You will not qualify if you...
- Presence of RET gene mutations in medullary thyroid cancer
- Prior treatment with zanzalintinib or tyrosine kinase inhibitors
- Recent anticancer therapy within 4 weeks or recent radiation therapy within specified time frames
- Known untreated or unstable brain metastases
- Use of certain oral anticoagulants or platelet inhibitors, except specified allowed anticoagulants
- Use of complementary medications for thyroid cancer within 2 weeks before treatment
- Uncontrolled or significant intercurrent illnesses including serious cardiovascular disorders, recent thrombotic events, significant bleeding events, symptomatic lung lesions, major blood vessel invasion, or other serious disorders
- Major surgery within 8 weeks or minor surgery within 5 days before treatment unless fully healed
- Prolonged QT interval >480 ms on ECG
- Psychiatric illness interfering with consent or protocol compliance
- Pregnant or lactating females
- Inability to swallow tablets or receive oral medication
- Allergy to study drug components
- Other active malignancies requiring therapy within 2 years, except some skin cancers or low-grade tumors
- Any condition that compromises safety or study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Mark Zafereo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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