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Exelixis XL184-311

Status:

Recruiting | Phase III 

Official Title:

A phase 3, randomized, double-blind, placebo-controlled study of cabozantinib (XL184) in subjects with radioiodine-refractory differentiated thyroid cancer who have progressed after prior VEGFR-targeted therapy

Study Purpose:

To evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior VEGFR-Targeted therapy.

Interventions:

  • Cabozantinib arm: Oral cabozantinib (60 mg) once a day
  • Placebo arm:  Oral cabozantinib-matched placebo once a day
  • The study will randomize to placebo to crossover to receive cabozantinib upon experiencing disease progression.

No further follow-up is required once completed the post-treatment follow-up visit.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Histologically or cytologically confirmed diagnosis of differential thyroid cancer including papillary, follicular, and other variants.

Marker Status:

Selective small-molecule BRAF kinase inhibitor.

Eligibility:

More than 2 VEGFR-targeting TKI agents.

More than 1 immune checkpoint inhibitor therapy and more than 1 systemic chemotherapy regimen.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Exelixis XL184-311

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!