A Phase 2 Open Label Study of XL092 as First Line Therapy in Radioiodine Refractory Differentiated Thyroid Cancer
Northwestern University
Summary
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.
Description
PRIMARY OBJECTIVE: I. Assess efficacy of the treatment zanzalintinib (XL092) in radioiodine refractory/radioactive iodine refractory (RAIR) differentiated thyroid cancer (DTC) patients by evaluating the proportion of patients alive and without progression at 12 months. SECONDARY OBJECTIVES: I. Assess efficacy of XL092 treatment in RAIR DTC patients by imaging. II. Assess efficacy of the treatment XL092 in RAIR DTC patients by evaluating progression free survival. III. Assess efficacy for RAIR DTC patients treated with XL092 evaluating the overall survival time. IV. Assess the safety and t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have a histologically confirmed locally advanced or metastatic, radioactive iodine (RAI) refractory, differentiated thyroid cancer (including papillary, follicular, and oncocytic/Hurthle cell, and poorly differentiated thyroid cancer \[PDTC\]), with progression within 12 months (per Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1 response criteria) prior to study registration, and no prior therapy in the RAI-refractory setting and for which standard curative or palliative measures do not exist or are no longer effective. * NOTE:…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- OtherSurvey Administration
Ancillary studies
- ProcedureX-Ray Imaging
Undergo x-ray imaging
- DrugZanzalintinib
Given PO
Location
- Northwestern UniversityChicago, Illinois