XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer
A Phase 2 Open Label Study of XL092 as First Line Therapy in Radioiodine Refractory Differentiated Thyroid Cancer
Sponsor: Northwestern University + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression free survival (PFS)
Time frame: From the time of the first dose of XL092 to the first documentation of disease progression, initiation of subsequent anti-cancer therapy, completion of 12 months of participation, or death from any cause, whichever occurs first, assessed at 12 months
Secondary Endpoints
Radiographic response rate
Overall PFS
Overall survival (OS)
Eligibility Criteria
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: RAI refractoriness is defined as absence of uptake of RAI on either a low-dose diagnostic test or a post-treatment RAI scan in measurable lesions or radiographic progression of disease within 12 months of the last course of RAI treatment despite the recorded uptake of RAI with that previous therapy or having a cumulative lifetime administered dose of ≥ 600mCi. * Poorly differentiated thyroid ca…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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