Clinical trial NCT01878448: A Phase II Study of Anlotinib in STS Patients
Official title: Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: tumor size
timeFrame: each 42 days up to 48 months
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: each 21 days up to 48 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The 1st affiliated hospital of bengbu medical college
state: Anhui
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Province Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Meidical University
state: Fujian
city: Lanzhou
country: China
facility: Gansu Province Tumor Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi medical university affiliated tumor hospital
state: Guangxi
city: Harbin
country: China
facility: Harbin medical university affiliated tumor hospital
state: Heilongjiang
city: Shenyang
country: China
facility: Liaoning Province Tumor Hospital
state: Liaoning
city: Shanghai
country: China
facility: Cancer Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
References: