NCT01118065

Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with progressive or recurrent, unresectable, or metastatic thyroid cancer.

Detailed description

OBJECTIVES: Primary * To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma. Secondary * 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. (exploratory) * To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer. 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	everolimus

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-05-01
• First posted: 2010-05-06
• Last updated: 2013-08-12

Locations

1 site across 1 country: Netherlands