Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To look at the effectiveness of zanzalintinib, followed by surgery, in treating advanced thyroid cancer. The safety of this treatment will also be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 extra nodal extension, or with advanced recurrent/residual invasive/bulky nodal disease will be enrolled in this trial, regardless of whether distant metastases are present or not.
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 patients with Bethesda IV or V FNA's (e.g. follicular neoplasm, follicular lesion, Hürthle cell neoplasm, Hürthle cell lesion), if the radiographic context is conclusive for carcinoma of thyroid origin, including significant extrathyroidal extension with invasion of surrounding structures and PET avidity, patients can be enrolled.
Thyroid Neck Group morbidity complexity score of 1 to 4 (moderate, severe, very severe, or unresectable).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Zanzalintinib
DrugGiven by po
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant with Zanzalintinib Followed by SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and adverse events
Defined as the proportion of patients who have a MR, PR, or CR per modified RECIST 1.1. CR and PR are defined using the same criteria as in RECIST 1.1. MR is defined as a 15% or greater decrease in the sum of the longest diameters of target lesions but not a PR. The MR+PR+CR response rate will be determined by dividing the number of patients with modified RECIST-based MR, PR, or CR divided by the number of evaluable patients
Time frame
From baseline until completion of neoadjuvant therapy; an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Exelixis
Collaborator
Source ClinicalTrials.gov