Actively Recruiting
XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer
Led by Northwestern University · Updated on 2025-06-11
33
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well XL092 works for the treatment of patients with differentiated thyroid cancer that has not responded to previous treatment with radioiodine (radioiodine refractory) and that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). XL092 is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing.
CONDITIONS
Official Title
XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically confirmed locally advanced or metastatic differentiated thyroid cancer that is refractory to radioactive iodine treatment and has progressed within 12 months prior to registration
- Patients must have measurable disease according to RECIST version 1.1
- Patients must be 18 years of age or older
- Patients must have an ECOG performance status of 0 to 2
- Leukocytes (WBC) of 3000/mcL or higher
- Absolute neutrophil count (ANC) of 1500/mcL or higher
- Hemoglobin (Hgb) of 9 g/dL or higher
- Platelets (PLT) of 100,000/mcL or higher
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal (ULN), or up to 3 times ULN if patient has Gilbert's disease
- AST (SGOT) less than or equal to 3 times ULN
- ALT (SGPT) less than or equal to 3 times ULN
- Alkaline phosphatase (ALP) less than or equal to 3 times ULN, or up to 5 times ULN for patients with documented bone metastasis
- Creatinine clearance (CrCl) of 40 mL/min or higher using Cockcroft-Gault equation
- INR less than or equal to 1.5 times ULN if not on anticoagulation
- aPTT less than or equal to 1.2 times ULN if not on anticoagulation
- Urine protein-to-creatinine ratio (UPCR) less than or equal to 1 mg/mg
- Patients with HIV must be on stable antiretroviral therapy with undetectable viral load for 6 months, CD4+ T cell count of 200/µL or higher, and no uncontrolled infection
- Patients with treated brain metastases are eligible if stable and no progression for at least 4 weeks
- Female patients of childbearing potential must have a negative pregnancy test prior to registration
- Patients and partners must agree to use highly effective contraception during and after the study for specified durations
- Recovery to baseline or grade 1 or less from prior treatment side effects except alopecia and neuropathy
- Ability and willingness to sign informed consent and comply with study requirements
- Ability to swallow and absorb oral medication
You will not qualify if you...
- Prior treatment with XL092 (zanzalintinib)
- Active hepatitis B infection
- Active hepatitis C infection unless treated and with negative RNA test
- Pregnant or nursing women
- Receipt of kinase inhibitor treatment within 2 weeks before study treatment
- Receipt of cytotoxic, biologic, or systemic anticancer therapy within 4 weeks before study treatment
- Radiation therapy within 2 to 6 weeks before study treatment depending on type
- Allergy or hypersensitivity to XL092 or similar compounds
- Concomitant use of certain oral anticoagulants or high-dose aspirin
- Uncontrolled or significant cardiovascular disorders including recent heart attack, stroke, or unstable angina
- Gastrointestinal disorders with high risk of perforation or recent serious GI events
- Other uncontrolled illnesses or infections needing systemic treatment
- Serious non-healing wounds, ulcers, or fractures
- Malabsorption syndrome
- Symptomatic hypothyroidism not controlled by medication
- Moderate to severe liver impairment
- Requirement for dialysis
- History of organ or stem cell transplant
- Significant bleeding events within 12 weeks before study treatment
- Symptomatic pulmonary lesions or major blood vessel invasion
- Recent major surgery or incomplete healing
- QTc interval over 480 ms on ECG
- Psychiatric illness interfering with consent or compliance
- Other active malignancies within 2 years except certain low-risk tumors
- Receipt of live attenuated vaccines within 30 days before or during study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
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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