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A Phase II Study of Anlotinib in STS Patients (ALTN/STS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01878448
First received: May 30, 2013
Last updated: April 5, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: Anlotinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd:

Primary Outcome Measures:
  • tumor size [ Time Frame: 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:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anlotinib Drug: Anlotinib

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878448

Locations
China, Anhui
The 1st affiliated hospital of bengbu medical college
Bengbu, Anhui, China
China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Chinese PLA General Hospital
Beijing, Beijing, China, 100039
Beijing Cancer Hospital
Beijing, Beijing, China
Beijing Jishuitan Hospital
Beijing, Beijing, China
Peking Union Medical College Hospital
Beijing, Beijing, China
China, Fujian
Fujian Province Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Meidical University
Fuzhou, Fujian, China
China, Gansu
Gansu Province Tumor Hospital
Lanzhou, Gansu, China
China, Guangdong
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
China, Guangxi
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, China
China, Heilongjiang
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang, China
China, Liaoning
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
China, Shanghai
Cancer Hospital of Fudan University
Shanghai, Shanghai, China
Shanghai 6th People's Hospital
Shanghai, Shanghai, China
China, Tianjin
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
  More Information

Responsible Party: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT01878448     History of Changes
Other Study ID Numbers: ALTN-02-II 
Study First Received: May 30, 2013
Last Updated: April 5, 2016

ClinicalTrials.gov processed this record on February 24, 2017