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| Sponsor: | Yonsei University |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01164176 |
Purpose
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: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer |
| Estimated Enrollment: | 32 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed thyroid cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| Korea, Republic of | |
| Hallym University Sacred Heart Hospital | Recruiting |
| Anyang, Gyeonggi-do, Korea, Republic of, 431-070 | |
| Contact: Contact Person 82-31-380-3704 | |
| Yeungnam University Medical Center | Recruiting |
| Daegu, Korea, Republic of, 712-749 | |
| Contact: Contact Person 82-53-620-4683 | |
| National Cancer Center - Korea | Recruiting |
| Goyang, Korea, Republic of, 410-769 | |
| Contact: Contact Person 82-31-920-1621 | |
| Kosin Medical Center Gospel Hospital | Recruiting |
| Pusan, Korea, Republic of, 602-702 | |
| Contact: Contact Person 82-51-990-6107 | |
| Yonsei Cancer Center at Yonsei University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Contact Person 82-2-2228-8138 cbc1971@yuhs.ac | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Contact Person 82-2-2072-3559 | |
| Gangnam Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 135-720 | |
| Contact: Contact Person 82-2-2019-3297 | |
| Principal Investigator: | Byung Chul Cho | Yonsei University |
More Information
| ClinicalTrials.gov Identifier: | NCT01164176 History of Changes |
| Other Study ID Numbers: | CDR0000681136, YONSEI-CRAD001CKR12T, KCSG-HN-10-03 |
| Study First Received: | July 15, 2010 |
| Last Updated: | July 15, 2010 |
| Health Authority: | Unspecified |
|
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 Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Thyroid Diseases Everolimus Sirolimus Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |