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The purpose of the study is to determine if AMG 706 will have clinically meaningful anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are not candidates for radioactive iodine therapy or local therapies.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 706 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (complete response and partial response) as defined by modified RECIST |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | ||
| Progression Free Survival | ||
| Changes in tumor markers |
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Inclusion Criteria: - Histologically confirmed locally advanced or metastatic thyroid cancer - Measurable disease - Normal blood pressure (if history of hypertension, blood pressure must be controlled with medication) - Evidence of disease progression within 6 months before starting study (for differentiated thyroid cancer subjects) - Evidence of disease progression within 6 months before starting study OR symptomatic disease (for medullary thyroid cancer subjects) - Not a candidate for surgical resection, external beam radiotherapy, radioiodine therapy, or other local therapy - At least 18 years of age Exclusion Criteria: - Undifferentiated/anaplastic thyroid cancer - Untreated or symptomatic brain metastases - Prior malignancy, unless cured with treatment and no evidence of disease for greater than or equal to 3 years before starting study (history of thyroid cancer, in situ cervical cancer, or basal cell cancer of skin are exceptions) - Myocardial infarction or any unstable cardiac condition (e.g., congestive heart failure, unstable angina) within 1 year before starting study - Arterial thrombosis or deep vein thrombosis within 1 year before starting study
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Sherman SI, Wirth L, Droz J-P, Hofmann M, Bastholt L, Martins R, Licitra L, Eschenberg M, Sun Y-N, J | ||
| 20739388 | Derived | Bass MB, Sherman SI, Schlumberger MJ, Davis MT, Kivman L, Khoo HM, Notari KH, Peach M, Hei YJ, Patterson SD. Biomarkers as predictors of response to treatment with motesanib in patients with progressive advanced thyroid cancer. J Clin Endocrinol Metab. 2010 Nov;95(11):5018-27. doi: 10.1210/jc.2010-0947. Epub 2010 Aug 25. | |
| 18596272 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D018276 | Carcinoma, Medullary |
| D018263 | Adenocarcinoma, Follicular |
| D000077273 | Thyroid Cancer, Papillary |
| C536913 | Thyroid cancer, Hurthle cell |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C000625785 | motesanib diphosphate |
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| overall survival time |
| time to response |
| Tumour Related Symptoms (medullary thyroid cancer arm) |
| AMG 706 pharmacokinetic profile |
| patient reported outcome (EQ-5D) |
| Safety Endpoint: Incidence of treatment-emergent adverse events (including all, serious, treatment-related, and each by maximum severity). |
| Pharmacokinetic Enpoint: AMG 706 pharmacokinetic parameters (Cmax, t1/2, AUC0-24,C24) |
| Derived |
| Sherman SI, Wirth LJ, Droz JP, Hofmann M, Bastholt L, Martins RG, Licitra L, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Schlumberger MJ; Motesanib Thyroid Cancer Study Group. Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med. 2008 Jul 3;359(1):31-42. doi: 10.1056/NEJMoa075853. |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
| D000231 | Adenocarcinoma, Papillary |