A Phase II Study of Anlotinib in STS Patients
ALTN/STS
Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma
1 other identifier
interventional
166
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Apr 2013
Typical duration for phase_2 cancer
16 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
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
June 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2017
CompletedMay 22, 2019
May 1, 2019
2.5 years
May 30, 2013
May 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
each 21 days up to 48 months
Study Arms (1)
Anlotinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- ×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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
The 1st affiliated hospital of bengbu medical college
Bengbu, An'hui, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Province Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Meidical University
Fuzhou, Fujian, China
Gansu Province Tumor Hospital
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, China
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2013
First Posted
June 17, 2013
Study Start
April 1, 2013
Primary Completion
October 1, 2015
Study Completion
April 30, 2017
Last Updated
May 22, 2019
Record last verified: 2019-05