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Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

Head and Neck Cancer Clinical Trial

Official title:
An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer

Clinical Trial 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 locally advanced or metastatic thyroid cancer.

Clinical Trial Description

OBJECTIVES:

Primary

- To evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus.

Secondary

- 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01164176
Study type Interventional
Source Yonsei University
Contact
Status Completed
Phase Phase 2
Start date March 2010
Completion date October 2014
View Details
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