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New treatment option for Neoadjuvant Treatment
Official title Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery
ClinicalTrials.gov ID: NCT06959511
What this study is testing
What is Zanzalintinib?
Zanzalintinib is an investigational medicine, being studied as a potential treatment for neoadjuvant treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To look at the effectiveness of zanzalintinib, followed by surgery, in treating advanced thyroid cancer. The safety of this treatment will also be studied.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria
- Participants with differentiated thyroid cancer, non-RET-mutated medullary thyroid cancer, or poorly differentiated thyroid cancer who present with...
- At least 18 years of age on the day of signing informed consent.
- Pathologic findings supporting the clinical impression of papillary thyroid cancer, follicular thyroid cancer, oncocytic thyroid cancer, medullary...
- Thyroid Neck Group morbidity complexity score of 1 to 4 (moderate, severe, very severe, or unresectable).
You likely can't join if
- Medullary thyroid cancer participants with germline RET or known somatic RET mutations.
- Prior treatment with zanzalintinib.
- Prior treatment with a tyrosine kinase inhibitor.
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study...
- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic...
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for...
See the full eligibility criteria
Who can join
- Eligibility Criteria
- Participants with differentiated thyroid cancer, non-RET-mutated medullary thyroid cancer, or poorly differentiated thyroid cancer who present with locoregionally advanced disease, as defined by extrathyroidal and/or...
- At least 18 years of age on the day of signing informed consent.
- Pathologic findings supporting the clinical impression of papillary thyroid cancer, follicular thyroid cancer, oncocytic thyroid cancer, medullary thyroid carcinoma, and/or poorly differentiated thyroid carcinoma. For...
- Thyroid Neck Group morbidity complexity score of 1 to 4 (moderate, severe, very severe, or unresectable).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 with no known sudden deterioration 2 weeks prior to the first dose of trial treatment.
- Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable...
- Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 28 days before first dose of study treatment:
- Absolute neutrophil count (ANC)≥ 1500/mm3 (≥1.5 GI/L) without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.
- Platelets ≥ 100,000/mm3 (≥100 GI/L) without transfusion within 2 weeks of screening laboratory sample collection.
- Hemoglobin ≥9 g/dL (≥90 g/L) without transfusion within 2 weeks prior to screening laboratory sample collection.
- International Normalized Ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN).
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x ULN. For people with documented bone metastasis ALP ≤5 x ULN.
- Total bilirubin ≤ 1.5 x ULN (for people with Gilbert fs disease ≤ 3 x ULN).
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL/min ( ≥0.67 mL/sec) using the Cockcroft Gault equation.
- Urine protein-to-creatinine ratio (UPCR) ≤1 mg/mg ( ≤113.2 mg/mmol) creatinine.
- Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
- For MD Anderson site only, people must be willing to undergo tumor biopsy prior to trial treatment, unless in the opinion of the treating physician, a biopsy is not feasible or safe. For all sites, people must be...
- Sexually active fertile people and their partners must agree to use highly effective method of contraception (defined in Appendix A) during the course of the study and for the following durations after the last dose of...
- Female people of childbearing potential must not be pregnant at screening. Female people are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy...
What rules you out
- Medullary thyroid cancer participants with germline RET or known somatic RET mutations.
- Prior treatment with zanzalintinib.
- Prior treatment with a tyrosine kinase inhibitor.
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study...
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible...
- Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin inhibitors) and platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
- Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
- Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in people without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week...
- Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
- The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: a. Unstable or deteriorating cardiovascular disorders: i. Congestive heart failure...
- Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study...
- Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed. Intratracheal disease is allowed, as long as the endotracheal disease is not associated with major bleeding...
- Lesions invading major blood vessel including, but are not limited to, inferior vena cava, pulmonary artery, or aorta. Note: people with internal jugular vein involvement or tumor thrombus in the neck are eligible...
- Other clinically significant disorders that would preclude safe study participation.
- Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.
- Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)- related illness except for people meeting all of the following criteria: (1)...
- Serious non-healing wound/ulcer/bone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.
- Malabsorption syndrome.
- Uncontrolled symptomatic hyperthyroidism or hypothyroidism.
- Uncontrolled symptomatic hypercalcemia or hypocalcemia.
- Moderate to severe hepatic impairment (Child-Pugh B or C).
- Requirement for hemodialysis or peritoneal dialysis.
- History of solid organ or allogeneic stem cell transplant.
- Major surgery (as defined in Appendix B; e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5...
- Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.
- History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
- Pregnant or lactating females.
- Inability to swallow tablets or ingest a suspension either orally or by nasogastric (NG) or gastrostomy (PEG) tube.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose...
- Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participants ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States; Houston, Texas, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.