Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

This study has been completed.
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
First received: July 15, 2010
Last updated: November 26, 2014
Last verified: February 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 Intervention Phase
Head and Neck Cancer
Drug: everolimus
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Response rate [ Time Frame: every 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: participants will be followed until death ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: participants will be followed until disease progression or death ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: participants will be followed until disease progression or death ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 group Drug: everolimus Other: laboratory biomarker analysis

Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed thyroid cancer

    • Progressive or refractory disease within the past 6 months
    • Locally advanced or metastatic disease
  • Measurable disease, defined as ≥ 1 measurable lesion defined by RECIST criteria
  • Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy
  • No untreated brain metastasis


  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine < 1.5 mg/dL
  • Total bilirubin ≤ 1.0 times upper limit of normal (ULN)
  • ALT and AST ≤ 3.0 times ULN
  • No known hypersensitivity to the study drug
  • No serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes)
  • No history of significant neurological or mental disorder, including seizures or dementia
  • No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin
  • No active uncontrolled cardiac disease
  • No myocardial infarction within the past 12 months
  • Able to take oral medication
  • No active peptic ulcer disease
  • Must have patient compliance and geographic proximity for adequate follow-up


  • At least 30 days since prior mTor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy
  • At least 2 weeks since prior and no concurrent P-glycoprotein, CYP3A4, and CYP3A5 inhibitors or inducers
  • No prior surgical procedure affecting absorption
  • No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Sponsors and Collaborators
Yonsei University
Principal Investigator: Byung Chul Cho Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01164176     History of Changes
Other Study ID Numbers: 4-2009-0542  YONSEI-CRAD001CKR12T  KCSG-HN-10-03 
Study First Received: July 15, 2010
Last Updated: November 26, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
anaplastic thyroid cancer
insular thyroid cancer
recurrent thyroid cancer
stage III follicular thyroid cancer
stage III papillary thyroid cancer
stage IV follicular thyroid cancer
stage IV papillary thyroid cancer
thyroid gland medullary carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Thyroid Diseases
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016