Skip to main content
OpenTrials
Completed

NCT Number: NCT01878448

A Phase II Study of Anlotinib in STS Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The 1st affiliated hospital of bengbu medical college, Bengbu, An'hui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anlotinib

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

Phase 2 Study of Anlotinib in Advanced Soft Tissue Sarcoma

Acronym: ALTN/STS

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Jun 17, 2013
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.