Study of Anlotinib in Patients With Primary Malignant Bone Tumors
Primary Purpose
Neoplasm of Bone
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm of Bone
Eligibility Criteria
Inclusion Criteria:
- The patient volunteered to participate in this study and signed an informed consent;
- Pathological diagnosis of osteosarcoma, chondrosarcoma, source of undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, derived bone giant cell tumor of bone or bone primary Ewing's sarcoma / primitive neuroectodermal tumor (PNET) tumor;
- All patients were failed in chemotherapy (including anthracycline) or intolerance, recurrence or distant metastasis, and at least one measurable lesion (according to RECIST 1.1 criteria);
- At the age of 14-70, less than 18 year old patients with body surface area to more than 1.5m2;
- ECOG PS score: 0~1 score (amputation patient's PS score is 0~2), and the expected survival time is over March;
- The main organs function within 7 days before the treatment, in accordance with the following criteria: the standard of blood routine examination (in 14 days without blood transfusion): The hemoglobin is greater than or equal to 90g/L (by multiple tumor metastasis induced anemia, hemoglobin = 85g/L); The neutrophil absolute value is more than 1.5 * 109/L; Platelet over 80 * 109/L. biochemical examination should comply with the following criteria: The total bilirubin is less than or equal to 1.5 Long ULN; The alanine aminotransferase and aspartate aminotransferase is less than or equal to 2.5ULN, such as liver metastasis, ALT and AST = 5ULN; The serum creatinine or creatinine clearance rate is greater than 1.5ULN 60ml/min; Doppler ultrasound assessment of the lower limit of normal value is more than the left ventricular ejection fraction (50%).
- Women of childbearing age should use contraceptive measures must be agreed within 6 months in the study period and after the end of the study (such as IUD, pill or condoms); in the study before entering the group within 7 days of serum or urine pregnancy test is negative, and must be for patients with non lactation; men should agree to use contraceptive measures must be 6 months in the research period and the end of the study period after the patients.
Exclusion Criteria:
- Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C
Sites / Locations
- Beijing Jishuitan Hospital
- Beijing Cancer Hospital
- Henan Cancer Hospital
- Shanghai No.6 People's Hospital
- The First Affiliated Hospital of the Air Force Medical University
- West China Hospital of Sichuan University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Anlotinib
Arm Description
Anlotinib 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)
From random grouping to the objective progression or death of a tumor
Secondary Outcome Measures
Overall Survival (OS)
The time in which the group begins to cause death for any reason
Full Information
NCT ID
NCT03527888
First Posted
April 18, 2018
Last Updated
May 20, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03527888
Brief Title
Study of Anlotinib in Patients With Primary Malignant Bone Tumors
Official Title
A Single-Arm, Open-Label, Multicenter Clinical Trial With Anlotinib Hydrochloride Capsule for Primary Malignant Bone Tumors With Recurrence and Distant Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of patients with recurrent and metastatic bone tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm of Bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib
Arm Type
Other
Arm Description
Anlotinib 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 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Primary Outcome Measure Information:
Title
Progress free survival (PFS)
Description
From random grouping to the objective progression or death of a tumor
Time Frame
through study completion, an average of 6 month
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The time in which the group begins to cause death for any reason
Time Frame
through study completion, an average of 10 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient volunteered to participate in this study and signed an informed consent;
Pathological diagnosis of osteosarcoma, chondrosarcoma, source of undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, derived bone giant cell tumor of bone or bone primary Ewing's sarcoma / primitive neuroectodermal tumor (PNET) tumor;
All patients were failed in chemotherapy (including anthracycline) or intolerance, recurrence or distant metastasis, and at least one measurable lesion (according to RECIST 1.1 criteria);
At the age of 14-70, less than 18 year old patients with body surface area to more than 1.5m2;
ECOG PS score: 0~1 score (amputation patient's PS score is 0~2), and the expected survival time is over March;
The main organs function within 7 days before the treatment, in accordance with the following criteria: the standard of blood routine examination (in 14 days without blood transfusion): The hemoglobin is greater than or equal to 90g/L (by multiple tumor metastasis induced anemia, hemoglobin = 85g/L); The neutrophil absolute value is more than 1.5 * 109/L; Platelet over 80 * 109/L. biochemical examination should comply with the following criteria: The total bilirubin is less than or equal to 1.5 Long ULN; The alanine aminotransferase and aspartate aminotransferase is less than or equal to 2.5ULN, such as liver metastasis, ALT and AST = 5ULN; The serum creatinine or creatinine clearance rate is greater than 1.5ULN 60ml/min; Doppler ultrasound assessment of the lower limit of normal value is more than the left ventricular ejection fraction (50%).
Women of childbearing age should use contraceptive measures must be agreed within 6 months in the study period and after the end of the study (such as IUD, pill or condoms); in the study before entering the group within 7 days of serum or urine pregnancy test is negative, and must be for patients with non lactation; men should agree to use contraceptive measures must be 6 months in the research period and the end of the study period after the patients.
Exclusion Criteria:
- Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Yao
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Jishuitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Shanghai No.6 People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
The First Affiliated Hospital of the Air Force Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Anlotinib in Patients With Primary Malignant Bone Tumors
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