A Phase II Study of Anlotinib in STS Patients
- Registration Number
- NCT01878448
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
-
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.
-
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anlotinib Anlotinib -
- Primary Outcome Measures
Name Time Method tumor size each 42 days up to 48 months To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT scan every two cycles. Refer to recist 1.1.
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability each 21 days up to 48 months blood examination, urine examination, stool examination, blood biochemical (ALT, AST, TB(total bilirubin), DB, BUN, Cr, blood electrolyte), electrocardiogram (ecg), thyroid function, the function of blood coagulation, etc
Trial Locations
- Locations (16)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Beijing Jishuitan Hospital
🇨🇳Beijing, Beijing, China
Fujian Province Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Meidical University
🇨🇳Fuzhou, Fujian, China
Guangxi medical university affiliated tumor hospital
🇨🇳Nanning, Guangxi, China
Liaoning Province Tumor Hospital
🇨🇳Shenyang, Liaoning, China
Tianjin Medical University Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Shanghai 6th People's Hospital
🇨🇳Shanghai, Shanghai, China
Harbin medical university affiliated tumor hospital
🇨🇳Harbin, Heilongjiang, China
Cancer Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
The 1st affiliated hospital of bengbu medical college
🇨🇳Bengbu, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Gansu Province Tumor Hospital
🇨🇳Lanzhou, Gansu, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China