Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)

Soft Tissue Sarcoma Clinical Trial

Official title:

A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02449343
• Other study ID #: ALTN-02-IIB
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: May 17, 2015
• Last updated: April 23, 2017
• Start date: May 12, 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 233
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Signed and dated informed consent

• 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:

• Prior treatment with Anlotinib

• 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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• Anlotinib
Anlotinib p.o. qd
• Placebo
Placebo p.o. qd

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The 1st Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Hunan Province Tumor Hospital	Changsha	Hunan
China	West China Hospital , Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Fujian Meidical University	Fuzhou	Fujian
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-sen university	Guangzhou	Guangdong
China	Harbin medical university affiliated tumor hospital	Harbin	Heilongjiang
China	Gansu Cancer Hospital	Lanzhou	Gansu
China	Henan Province Tumor Hospital	Luoyan	Henan
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	Guangxi medical university affiliated tumor hospital	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai 6th People's Hospital	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai	Shanghai
China	Liaoning Province Tumor Hospital	Shenyang	Liaoning
China	The Third Hospital of hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Hospital	Tianjin	Tianjin
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xian Jiaotong University	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival (PFS)		up to 24 months
Secondary	Overall Survival (OS)		up to 24 months
Secondary	Objective Response Rate (ORR)		up to 24 months
Secondary	Disease Control Rate (DCR)		up to 24 months