Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer
|ClinicalTrials.gov Identifier: NCT01118065|
Recruitment Status : Unknown
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 6, 2010
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: everolimus||Phase 2|
- 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. (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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2012|
- Maximum percentage of tumor reduction
- Activity time to event endpoints
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118065
|Leiden University Medical Center||Recruiting|
|Leiden, Netherlands, 2300 RC|
|Contact: Contact Person 31-71-526-3486 email@example.com|
|Principal Investigator:||Ellen Kapiteijn, MD, PhD||Leiden University Medical Center|