Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)
NCT ID: NCT02586350
Last Updated: 2019-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
91 participants
INTERVENTIONAL
2015-07-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anlotinib
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.
Anlotinib
Placebo
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.
Placebo
Placebo p.o. qd
Interventions
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Anlotinib
Placebo
Placebo p.o. qd
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
3. ECOG PS:0-1,Life expectancy of more than 6 months
4. main organs function is normal
Exclusion Criteria
2. Subjects received radiotherapy external exposure within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study
3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) \]
4. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin
5. Patients with factors that could affect oral medication (such as dysphagia etc.)
6. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\])
7. Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
18 Years
70 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 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, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
Jiangsu province tumor hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, 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, China
20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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ALTN-01-IIMTC
Identifier Type: -
Identifier Source: org_study_id
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