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

Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.

Study Overview

• Status: Unknown
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Drug: Anlotinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • The 1st Affiliated Hospital of Bengbu Medical College
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100021
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Beijing, Beijing, China
      • Beijing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Meidical University
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Gansu Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Sun Yat-sen University
  • Guangxi
    • Nanning, Guangxi, China
      • Guangxi Medical University Affiliated Tumor Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050051
      • The Third Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Harbin medical university affiliated tumor hospital
  • Henan
    • Luoyan, Henan, China
      • Henan Province Tumor Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Province Tumor Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • Liaoning Province Tumor Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China
      • Shanghai 6th people's hospital
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital Shanghai JiaoTong University School of Medicine
    • Shanghai, Shanghai, China, 200032
      • Fudan University Zhongshan Hospital
  • Shanxi
    • Xian, Shanxi, China
      • The First Affiliated Hospital of Xian Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital , Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Hospital
    • Tianjin, Tianjin, China, 300211
      • Tianjin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)
• 18-70years,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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib; Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Anlotinib; Anlotinib p.o. qd
Placebo Comparator: Placebo; Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Placebo; Placebo p.o. qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progress free survival (PFS)	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	up to 24 months
Overall Survival (OS)	up to 24 months
Disease Control Rate (DCR)	up to 24 months

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: May 17, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 23, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: ALTN-02-IIB