Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)
A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma
1 other identifier
interventional
233
1 country
25
Brief Summary
Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2015
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2015
CompletedFirst Submitted
Initial submission to the registry
May 17, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 25, 2017
April 1, 2017
1.9 years
May 17, 2015
April 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progress free survival (PFS)
up to 24 months
Secondary Outcomes (3)
Overall Survival (OS)
up to 24 months
Objective Response Rate (ORR)
up to 24 months
Disease Control Rate (DCR)
up to 24 months
Study Arms (2)
Anlotinib
EXPERIMENTALAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo
PLACEBO COMPARATORPlacebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- years,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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
The 1st Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Meidical University
Fuzhou, Fujian, China
Gansu Cancer Hospital
Lanzhou, Gansu, 730050, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Sun Yat-sen university
Guangzhou, Guangdong, China
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, China
The Third Hospital of hebei Medical University
Shijiazhuang, Hebei, 050051, China
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang, China
Henan Province Tumor Hospital
Luoyan, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, China
West China Hospital , Sichuan University
Chengdu, Sichuan, China
Tianjin Hospital
Tianjin, Tianjin Municipality, 300211, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2015
First Posted
May 20, 2015
Study Start
May 12, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
April 25, 2017
Record last verified: 2017-04