Status:
COMPLETED
A Phase II Study of Anlotinib in STS Patients
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 inh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2017
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01878448
Start Date
April 1 2013
End Date
April 30 2017
Last Update
May 22 2019
Active Locations (16)
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1
The 1st affiliated hospital of bengbu medical college
Bengbu, An'hui, China
2
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
3
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039
4
Beijing Cancer Hospital
Beijing, Beijing Municipality, China