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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000672171 | Registry Identifier | PDQ (Physician Data Query) | |
| EUDRACT-2009-016669-27 | |||
| EU-21037 | |||
| NL-31245-058-10 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum percentage of tumor reduction | ||
| Activity time to event endpoints | ||
| Toxicity |
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DISEASE CHARACTERISTICS:
Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:
Meeting any of the following thyroid cancer subtypes:
Must have received prior everolimus or other mTOR inhibitor therapy
Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Kapiteijn, MD, PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | 2300 RC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27169792 | Derived | de Wit D, Schneider TC, Moes DJ, Roozen CF, den Hartigh J, Gelderblom H, Guchelaar HJ, van der Hoeven JJ, Links TP, Kapiteijn E, van Erp NP. Everolimus pharmacokinetics and its exposure-toxicity relationship in patients with thyroid cancer. Cancer Chemother Pharmacol. 2016 Jul;78(1):63-71. doi: 10.1007/s00280-016-3050-6. Epub 2016 May 11. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D065646 | Thyroid Carcinoma, Anaplastic |
| D013964 | Thyroid Neoplasms |
| D018263 | Adenocarcinoma, Follicular |
| D000077273 | Thyroid Cancer, Papillary |
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| D009370 |
| Neoplasms by Histologic Type |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000230 | Adenocarcinoma |
| D000231 | Adenocarcinoma, Papillary |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |