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The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or locally advanced or metastatic medullary thyroid carcinoma (MTC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Sorafenib 400 mg bid continuous dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar,BAY43-9006) | Drug | Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability | 6 months | |
| Change in red blood cell count | Baseline and 6 months | |
| Change in white blood cell count | Baseline and 6 months | |
| Change in alanine aminotransaminase level (ALT) | Baseline and 6 months | |
| Change in aspartate aminotransferase level (AST) | Baseline and 6 months | |
| Change in blood pressure | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response based on RECIST 1.1 criteria | Baseline and every 56 days up to progressive disease,an expected average of 8 months | |
| Plasma concentration of sorafenib | Cycle 2 Day 1 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe | Hyōgo | 650-0011 | Japan | |||
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Progression-free survival (PFS) |
| Baseline to progression or death by any reason |
| Overall survival (OS) | Baseline to death by any reason |
| Response rate (RR) | RR based on RECIST 1.1 criteria | Baseline and every 56 days up to progressive disease |
| Disease control rate (DCR) | DCR based on RECIST 1.1 criteria | Baseline and every 56 days up to progressive disease |
| Maximum reduction from baseline in the target lesion size | Baseline and every 56 days up to progressive disease |
| Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline | MTC subjects only | Baseline and every 56 days up to progressive disease |
| Matsumoto |
| Nagano |
| 390-8621 |
| Japan |
| Bunkyo-ku | Tokyo | 113-8603 | Japan |
| Koto-ku | Tokyo | 135-8550 | Japan |
| Osaka | 545-8586 | Japan |
| 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 |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |