A Phase II Study to Investigate the Efficacy of RAD001 (Afinitor®, Everolimus) in Patients With Irresectable Recurrent or Metastatic Differentiated, Undifferentiated (Anaplastic) and Medullary Thyroid Carcinoma
- To determine the efficacy of everolimus in patients with progressive or recurrent,
unresectable, or metastatic differentiated thyroid carcinoma.
- To determine maximum percentage of tumor reduction in these patients.
- To describe activity time to event endpoints.
- To assess toxicity.
- To determine evolution of serum thyroglobulin.
- To perform explorative pharmacogenomic, pharmacokinetic, and translational studies.
- To investigate efficacy of everolimus in patients with progressive or recurrent,
unresectable or metastatic disease of undifferentiated (anaplastic) or medullary
OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every
28 days in the absence of disease progression or unacceptable toxicity.
Masking: Open Label, Primary Purpose: Treatment
Ellen Kapiteijn, MD, PhD
Leiden University Medical Center