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To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. Subjects who received Anlotinib will not be eligible for the open-label phase. |
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| Placebo | Placebo Comparator | Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | To compare the Progression-free Survival (PFS) of subjects with medullary thyroid carcinoma(MTC) with Anlotinib versus Placebo. | Date of randomization to the date of disease progression (measured every 6 weeks) or death (whichever occurs first) as determined by blinded independent imaging review(assessed up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo. | Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
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| Drug |
Placebo p.o. qd |
|
| Beijing Tongren Hospital |
| Beijing |
| Beijing Municipality |
| China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 404100 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | China |
| Gansu Province Tumor Hospital | Lanzhou | Gansu | China |
| Sun Yat-Sen University Cancer Center | Guozhou | Guangdong | China |
| Harbin medical university affiliated tumor hospital | Harbin | Heilongjiang | China |
| Henan Province Tumor Hospital | Zhengzhou | Henan | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hunan Province Tumor Hospital | Changsha | Hunan | China |
| Jiangsu province tumor hospital | Nanjing | Jiangsu | China |
| Jilin Cancer Hospital | Changchun | Jilin | 132000 | China |
| Liaoning Province Tumor Hospital | Shenyang | Liaoning | China |
| Cancer Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
| West China Hospital Of Sichuan University | Chongqing | Sichuan | 400010 | China |
| 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital . | Tianjin | Tianjin Municipality | 300600 | China |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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