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Phase 2 study of XL092 as first line therapy in radioiodine refractory differentiated thyroid cancer

This study assesses efficacy of treatment with XL092 (Zanzalintinib) in radioactive iodine refractory Differentiated Thyroid Cancer patients by evaluating the proportion of patients alive and without progression at 12 months, by evaluating Progression Free Survival, evaluating the overall survival time, safety and tolerability of the study drug and characterize the quality of life. Along with that the study would assess immune cell landscape before and after the treatment, and study genomic changes before and after treatment.

The duration for this study will last for approximately 26 months or until the time of progression of cancer. The participant will be asked to start the treatment within 14 days of screening. XL092 (study drug) is an oral agent and will be provided as tablets at 100mg dose to be taken by mouth once a day.

Each treatment cycle is 21 days (every three weeks). Participants will be followed from the end of study treatment either at a routine clinic visit or by phone call every 3 months for 12 months to document survival, patient health status and disease progression.

Eligibility Criteria
  • locally advanced or metastatic, radioactive iodine (RAI) refractory, differentiated thyroid cancer with progression within 12 months 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.
  • patient must be age of at least 18 years.

Principal InvestigatorLorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
Location(s)
  • Map it 675 N. Saint Clair St. Fifteenth Floor, Suite 200
    Chicago, IL
  • Map it 675 N. Saint Clair St.
    Chicago, IL
ClinicalTrials.gov IdentifierNCT06959641IRB number STU00223751
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