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Apatinib Second Line Treatment for Advanced Osteosarcoma and Soft Tissue Sarcomas ,Openting ,Single Center, One-armed Clinical Study.

Primary Purpose

Osteosarcoma, Advanced

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma, Advanced focused on measuring first-line treatment failure, one measurable lesion

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject joined the study of his or her own free will , signed informed consent;
  2. Subject that diagnosed with advanced osteosarcoma by pathology and first-line treatment failure, at least have one measurable lesion ; Or confirmed by the pathology of advanced soft tissue sarcomas, at least have one measurable lesion,main include Synovial sarcoma、 Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、 Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma、Malignant peripheral nerve sheath tumor、Undifferentiatedsarcoma、 Rhabdomyosarcoma、chondrosarcoma、Osteosarcoma、Dermato- fibrosarcoma protuberans、GIST、Primitiveneuroectodermal tumor、Inflammatory myofibroblastic tumor、Malignant mesothelioma; 3)Within the past 6 months, Subject using at least one chemotherapy regimens (including anthracycline-based) failured (except gland alveolar soft tissue sarcoma); 4)18 to 70 years (including 18 and 70 ), men and women there is no limited. 5)ECOG PS score: 0 ~ 1; 6)Estimated survival period more than 3 months; 7)Main organs function within 7 days before the treatment, meet the following criteria:

    1. Blood routine examination standard( without blood transfusion condition in 14 days) :HB≥90g/L;②ANC≥1.5×109/L;③PLT≥80×109/L
    2. Blood biochemical examination must meet the following criteria:

      ① TBIL≤1.5ULN ;②ALT and AST≤2.5ULN,if With hepatic metastatic carcinoma,ALT and AST≤5ULN;③Cr≤1.5ULN或CCr≥60ml/min;

    3. Doppler ultrasound assessment: LVEF normal or low limit (50%).

      Exclusion Criteria:

      - 1)Subject with hypertension, and after antihypertensive drug therapy can't to the normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), Ⅱ or higher level of coronary heart disease, arrhythmia (include QTc prolonging, male > 450 ms, female > 470 ms) and cardiac insufficiency; 2)Subject used targeted therapy of vascular endothelial growth inhibitor drug previous, include Sunitinib, Sorafenib ,bevacizumab, imatinib and so on.

      3)With other malignant tumor before or at the same time, but except the cured skin basal cell carcinoma and carcinoma in situ of cervix.

      4)Subject accepted anticancer therapy before with NCI CTCAE classification > 1 grade toxicity reaction.

      5)Has multi-factors that effect of oral drug absorption(, such as unable to swallow, nausea or vomiting, chronic diarrhea and intestinal obstruction, etc.); 6)Special note: subject with gastrointestinal bleeding risk can't enrolled the study, include: (1) there are active peptic ulcer lesions, and defecate occult blood (+ +);(2)Subject with medical history include Melena、hematemesis in three months;(3) Subject must be of gastroscopy with defecate occult blood, clear whether deposit organic gastrointestinal tract diseases; 7)Subject with coagulant function abnormality (INR > 1.5 x ULN, APTT > 1.5 x ULN), bleeding tendency; 8)Didn't heal wounds for a long time or fracture. 9)Subject with active bleeding or within 30 days after Major surgery. 10)Intracranial metastasis; 11)Pregnant or lactating women; 12)cell toxic drug therapy, radiation therapy 3 weeks after treatment; Once took two or more targeted drugs, or once took other targeted drugs 3 months before enrollment.

      13)Suffered from other malignant tumor for the past three years. 14)Investigator considered that there may be exist any situation that can damage subject or result in subject can't meet or carry out Investigator requests.

      15)huge transfer/recurrent lesions(tumor size greater than 5 cm). 16)malignant pleuraleffusion or peritoneal effusion, caused NCI CTCAE grading more than 2 levels of breathing difficulties; Description: oversized tumor load often indicates poor blood supply, lead to drug unable to effectively into the tumor, in order to accurately assess the treatment effects apatinib to the soft tissue sarcomas, Our study do not accept with huge transfer recurrent focal (tumor diameter greater than 5 cm) of the patients into groups temporarily .

      17)Allergy to any ingredient about apatinibshould be ruled out; 18)Subject with severe liver and renal failure (level 4) should be ruled out; 19)Subject has a history of psychiatric drugs abuse and can't quit or have a mental disorder; 20)According to the investigator's judgment, subject who has concomitant diseases that serious to endanger the safety or impact subject to complete the study.

Sites / Locations

  • Henan cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib

Arm Description

Apatinib 500mg/d from day 1 to day 28, repeated every 28 days until progressive Disease(PD) .

Outcomes

Primary Outcome Measures

progress free survival
time from study drug treatment to tumor progress

Secondary Outcome Measures

overall survival
Time from study drug treatment to die

Full Information

First Posted
May 18, 2017
Last Updated
May 22, 2017
Sponsor
Henan Cancer Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03163381
Brief Title
Apatinib Second Line Treatment for Advanced Osteosarcoma and Soft Tissue Sarcomas ,Openting ,Single Center, One-armed Clinical Study.
Official Title
Apatinib Second Line Treatment for Advanced Osteosarcoma and Soft Tissue Sarcomas ,Openting ,Single Center, One-armed Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
October 11, 2017 (Anticipated)
Study Completion Date
April 11, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting ,single center, one-armed clinical study.
Detailed Description
The treatment of bone and soft tissue sarcomas are usually surgery and chemotherapy,advanced cases cannot be removed through surgical method for multiple metastasis,advanced cases Most advanced cases with chemotherapy is given priority to, but the effect is not ideal.Apatinib main through inhibit VEGFR to give play to Anti-angiogenesis effect to treatment of malignant tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma, Advanced
Keywords
first-line treatment failure, one measurable lesion

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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib
Arm Type
Experimental
Arm Description
Apatinib 500mg/d from day 1 to day 28, repeated every 28 days until progressive Disease(PD) .
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib 500mg,po,qd,medicine to disease progression.
Primary Outcome Measure Information:
Title
progress free survival
Description
time from study drug treatment to tumor progress
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival
Description
Time from study drug treatment to die
Time Frame
up to 24 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
18 to 70 years (including 18 and 70 ).
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject joined the study of his or her own free will , signed informed consent; Subject that diagnosed with advanced osteosarcoma by pathology and first-line treatment failure, at least have one measurable lesion ; Or confirmed by the pathology of advanced soft tissue sarcomas, at least have one measurable lesion,main include Synovial sarcoma、 Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、 Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma、Malignant peripheral nerve sheath tumor、Undifferentiatedsarcoma、 Rhabdomyosarcoma、chondrosarcoma、Osteosarcoma、Dermato- fibrosarcoma protuberans、GIST、Primitiveneuroectodermal tumor、Inflammatory myofibroblastic tumor、Malignant mesothelioma; 3)Within the past 6 months, Subject using at least one chemotherapy regimens (including anthracycline-based) failured (except gland alveolar soft tissue sarcoma); 4)18 to 70 years (including 18 and 70 ), men and women there is no limited. 5)ECOG PS score: 0 ~ 1; 6)Estimated survival period more than 3 months; 7)Main organs function within 7 days before the treatment, meet the following criteria: Blood routine examination standard( without blood transfusion condition in 14 days) :HB≥90g/L;②ANC≥1.5×109/L;③PLT≥80×109/L Blood biochemical examination must meet the following criteria: ① TBIL≤1.5ULN ;②ALT and AST≤2.5ULN,if With hepatic metastatic carcinoma,ALT and AST≤5ULN;③Cr≤1.5ULN或CCr≥60ml/min; Doppler ultrasound assessment: LVEF normal or low limit (50%). Exclusion Criteria: - 1)Subject with hypertension, and after antihypertensive drug therapy can't to the normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), Ⅱ or higher level of coronary heart disease, arrhythmia (include QTc prolonging, male > 450 ms, female > 470 ms) and cardiac insufficiency; 2)Subject used targeted therapy of vascular endothelial growth inhibitor drug previous, include Sunitinib, Sorafenib ,bevacizumab, imatinib and so on. 3)With other malignant tumor before or at the same time, but except the cured skin basal cell carcinoma and carcinoma in situ of cervix. 4)Subject accepted anticancer therapy before with NCI CTCAE classification > 1 grade toxicity reaction. 5)Has multi-factors that effect of oral drug absorption(, such as unable to swallow, nausea or vomiting, chronic diarrhea and intestinal obstruction, etc.); 6)Special note: subject with gastrointestinal bleeding risk can't enrolled the study, include: (1) there are active peptic ulcer lesions, and defecate occult blood (+ +);(2)Subject with medical history include Melena、hematemesis in three months;(3) Subject must be of gastroscopy with defecate occult blood, clear whether deposit organic gastrointestinal tract diseases; 7)Subject with coagulant function abnormality (INR > 1.5 x ULN, APTT > 1.5 x ULN), bleeding tendency; 8)Didn't heal wounds for a long time or fracture. 9)Subject with active bleeding or within 30 days after Major surgery. 10)Intracranial metastasis; 11)Pregnant or lactating women; 12)cell toxic drug therapy, radiation therapy 3 weeks after treatment; Once took two or more targeted drugs, or once took other targeted drugs 3 months before enrollment. 13)Suffered from other malignant tumor for the past three years. 14)Investigator considered that there may be exist any situation that can damage subject or result in subject can't meet or carry out Investigator requests. 15)huge transfer/recurrent lesions(tumor size greater than 5 cm). 16)malignant pleuraleffusion or peritoneal effusion, caused NCI CTCAE grading more than 2 levels of breathing difficulties; Description: oversized tumor load often indicates poor blood supply, lead to drug unable to effectively into the tumor, in order to accurately assess the treatment effects apatinib to the soft tissue sarcomas, Our study do not accept with huge transfer recurrent focal (tumor diameter greater than 5 cm) of the patients into groups temporarily . 17)Allergy to any ingredient about apatinibshould be ruled out; 18)Subject with severe liver and renal failure (level 4) should be ruled out; 19)Subject has a history of psychiatric drugs abuse and can't quit or have a mental disorder; 20)According to the investigator's judgment, subject who has concomitant diseases that serious to endanger the safety or impact subject to complete the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weitao Yao
Phone
13298189535
Email
ywtwhm@163.com
Facility Information:
Facility Name
Henan cancer hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Ding
Phone
0371-65588251

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Temporarily not sure whether to be Shared the data.
Citations:
PubMed Identifier
31401903
Citation
Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
Results Reference
derived

Learn more about this trial

Apatinib Second Line Treatment for Advanced Osteosarcoma and Soft Tissue Sarcomas ,Openting ,Single Center, One-armed Clinical Study.

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