A Phase 2 Open Label Study of XL092 as First Line Therapy in Radioiodine Refractory Differentiated Thyroid Cancer
Jochen Lorch
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…