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

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

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



- 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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

every 3 month

Safety Issue:


Principal Investigator

Byung Chul Cho

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

March 2010

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Thyroid Neoplasms
  • Head and Neck Neoplasms