A Phase II Study of Anlotinib in STS Patients
This trial is active, not recruiting.
|Sponsor||Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd|
|Start date||April 2013|
|End date||October 2015|
|Trial size||200 participants|
|Trial identifier||NCT01878448, ALTN-02-II|
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The protocol is to explore ALTN for the effectiveness of advanced soft tissue sarcoma and security.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Bengbu, China||The 1st affiliated hospital of bengbu medical college||no longer recruiting|
|Beijing, China||Cancer Institute and Hospital, Chinese Academy of Medical Sciences||no longer recruiting|
|Beijing, China||Chinese PLA General Hospital||no longer recruiting|
|Beijing, China||Beijing Cancer Hospital||no longer recruiting|
|Beijing, China||Beijing Jishuitan Hospital||no longer recruiting|
|Beijing, China||Peking Union Medical College Hospital||no longer recruiting|
|Fuzhou, China||Fujian Province Cancer Hospital||no longer recruiting|
|Fuzhou, China||The First Affiliated Hospital of Fujian Meidical University||no longer recruiting|
|Lanzhou, China||Gansu Province Tumor Hospital||no longer recruiting|
|Guangzhou, China||Sun Yat-Sen University Cancer Center||no longer recruiting|
|Nanning, China||Guangxi medical university affiliated tumor hospital||no longer recruiting|
|Harbin, China||Harbin medical university affiliated tumor hospital||no longer recruiting|
|Shenyang, China||Liaoning Province Tumor Hospital||no longer recruiting|
|Shanghai, China||Cancer Hospital of Fudan University||no longer recruiting|
|Shanghai, China||Shanghai 6th People's Hospital||no longer recruiting|
|Tianjin, China||Tianjin Medical University Cancer Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: each 42 days up to 48 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: each 21 days up to 48 months
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - 1.Faild in introditional treatmeat, Mainly includes:MFH/liposarcoma/leiomyosarcoma/SS and others(MPNST/Fibrosarcoma/CCS/ASPS/AS/ES; 2.Receiveed at least one chemotherapy regimens treatment; 3.18-70years, ECOG:0-2,Expected survival period >3 months; 4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT - 80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase )≤1.5*ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5*ULN) ;TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF - LLN. 5.Used contraceptive during the study and after 6 months; 6.Volunteer. Exclusion Criteria: - 1. Received vascular endothelial growth inhibitor type of targeted therapy; 2.With the second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.AE>1 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.Hitory of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases.
|Official title||Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma|
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