Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
|ClinicalTrials.gov Identifier: NCT01164176|
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : December 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: everolimus Other: laboratory biomarker analysis||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|Experimental: RAD001 group||Drug: everolimus Other: laboratory biomarker analysis|
- Response rate [ Time Frame: every 3 month ]
- Overall survival [ Time Frame: participants will be followed until death ]
- Progression-free survival [ Time Frame: participants will be followed until disease progression or death ]
- Toxicity profile [ Time Frame: participants will be followed until disease progression or death ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164176
|Korea, Republic of|
|Hallym University Sacred Heart Hospital|
|Anyang, Gyeonggi-do, Korea, Republic of, 431-070|
|Yeungnam University Medical Center|
|Daegu, Korea, Republic of, 712-749|
|National Cancer Center - Korea|
|Goyang, Korea, Republic of, 410-769|
|Kosin Medical Center Gospel Hospital|
|Pusan, Korea, Republic of, 602-702|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Yonsei Cancer Center at Yonsei University Medical Center|
|Seoul, Korea, Republic of, 120-752|
|Gangnam Severance Hospital|
|Seoul, Korea, Republic of, 135-720|
|Principal Investigator:||Byung Chul Cho||Yonsei University|