Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)
NCT ID: NCT02449343
Last Updated: 2017-04-25
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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UNKNOWN
PHASE2/PHASE3
233 participants
INTERVENTIONAL
2015-05-12
2017-04-30
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
Anlotinib
Anlotinib p.o. qd
Placebo
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo
Placebo p.o. qd
Interventions
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Anlotinib
Anlotinib p.o. qd
Placebo
Placebo p.o. qd
Eligibility Criteria
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Inclusion Criteria
* Histological documentation of Soft Tissue Sarcoma,including Synovial sarcoma、Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma，With measurable disease.
* Within the past 6 months, using at least one failure of chemotherapy regimens (including anthracycline-based) in treating patients(except alveolar soft part sarcoma)
* 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
* Main organs function is normal
* The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it
Exclusion Criteria
* With pleural effusion or ascites, cause respiratory syndrome
* Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
* Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
* Symptoms of brain metastases cannot be controlled and treated within less than 2 months
* With severe and failed to controlled diseases
* Occurred venous thromboembolic events within 6 months
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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The 1st Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Meidical University
Fuzhou, Fujian, China
Gansu Cancer Hospital
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen university
Guangzhou, Guangdong, China
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, China
The Third Hospital of hebei Medical University
Shijiazhuang, Hebei, China
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang, China
Henan Province Tumor Hospital
Luoyan, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, China
West China Hospital , Sichuan University
Chengdu, Sichuan, China
Tianjin Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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ALTN-02-IIB
Identifier Type: -
Identifier Source: org_study_id
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