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Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)

Primary Purpose

Soft Tissue Sarcoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The 1st Affiliated Hospital of Bengbu Medical College
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Beijing Cancer Hospital
  • Peking Union Medical College Hospital
  • The First Affiliated Hospital of Fujian Meidical University
  • Gansu Cancer Hospital
  • Sun Yat-Sen University Cancer Center
  • The First Affiliated Hospital of Sun Yat-sen university
  • Guangxi medical university affiliated tumor hospital
  • The Third Hospital of hebei Medical University
  • Harbin medical university affiliated tumor hospital
  • Henan Province Tumor Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan Province Tumor Hospital
  • Jiangxi Cancer Hospital
  • Liaoning Province Tumor Hospital
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • Fudan University Shanghai Cancer Center
  • Fudan University Zhongshan Hospital
  • Shanghai General Hospital
  • Shanghai 6th People's Hospital
  • The First Affiliated Hospital of Xian Jiaotong University
  • West China Hospital , Sichuan University
  • Tianjin Hospital
  • Tianjin Medical University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anlotinib

Placebo

Arm Description

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Outcomes

Primary Outcome Measures

Progress free survival (PFS)

Secondary Outcome Measures

Overall Survival (OS)
Objective Response Rate (ORR)
Disease Control Rate (DCR)

Full Information

First Posted
May 17, 2015
Last Updated
April 23, 2017
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02449343
Brief Title
Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)
Official Title
A Registered Randomized, Double-Blind, Placebo-Controlled (2:1), Multi-Centered Clinical Trial of Anlotinib as a Treatment for Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2015 (Actual)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib
Arm Type
Experimental
Arm Description
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
Anlotinib p.o. qd
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo p.o. qd
Primary Outcome Measure Information:
Title
Progress free survival (PFS)
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
up to 24 months
Title
Objective Response Rate (ORR)
Time Frame
up to 24 months
Title
Disease Control Rate (DCR)
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The 1st Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Meidical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Gansu Cancer Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen university
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangxi medical university affiliated tumor hospital
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
The Third Hospital of hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
Harbin medical university affiliated tumor hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Henan Province Tumor Hospital
City
Luoyan
State/Province
Henan
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hunan Province Tumor Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Facility Name
Liaoning Province Tumor Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Shanghai 6th People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Xian Jiaotong University
City
Xian
State/Province
Shanxi
Country
China
Facility Name
West China Hospital , Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

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Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)

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