A Phase II Study of Anlotinib in STS Patients

Cancer Clinical Trial

— ALTN/STS  

Official title:

Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878448
• Other study ID #: ALTN-02-II
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: April 30, 2017

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 30, 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Anlotinib

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The 1st affiliated hospital of bengbu medical college	Bengbu	Anhui
China	Fujian Province Cancer Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Fujian Meidical University	Fuzhou	Fujian
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Harbin medical university affiliated tumor hospital	Harbin	Heilongjiang
China	Gansu Province Tumor Hospital	Lanzhou	Gansu
China	Guangxi medical university affiliated tumor hospital	Nanning	Guangxi
China	Cancer Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai 6th People's Hospital	Shanghai	Shanghai
China	Liaoning Province Tumor Hospital	Shenyang	Liaoning
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor size	To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT scan every two cycles. Refer to recist 1.1.	each 42 days up to 48 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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	each 21 days up to 48 months