An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer
- To evaluate response rate in patients with locally advanced or metastatic, unresectable
or refractory thyroid cancer treated with everolimus.
- To evaluate overall survival of these patients treated with everolimus.
- To evaluate progression-free survival of these patients.
- To evaluate toxicity of this therapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in
the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative studies.
After completion of study treatment, patients are followed up for 12 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
every 3 month
Byung Chul Cho
South Korea: Korea Food and Drug Administration (KFDA)