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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03163381
Recruitment Status : Unknown
Verified May 2017 by YaoWeitao, Henan Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
YaoWeitao, Henan Cancer Hospital

Brief Summary:
Apatinib second line treatment for Advanced osteosarcoma and soft tissue sarcomas ,openting ,single center, one-armed clinical study.

Condition or disease Intervention/treatment Phase
Osteosarcoma, Advanced Drug: Apatinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apatinib Second Line Treatment for Advanced Osteosarcoma and Soft Tissue Sarcomas ,Openting ,Single Center, One-armed Clinical Study.
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : October 11, 2017
Estimated Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib
Apatinib 500mg/d from day 1 to day 28, repeated every 28 days until progressive Disease(PD) .
Drug: Apatinib
Apatinib 500mg,po,qd,medicine to disease progression.




Primary Outcome Measures :
  1. progress free survival [ Time Frame: 6 months ]
    time from study drug treatment to tumor progress


Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to 24 months ]
    Time from study drug treatment to die



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18 to 70 years (including 18 and 70 ).
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163381


Contacts
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Contact: Weitao Yao 13298189535 ywtwhm@163.com

Locations
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China, Henan
Henan cancer hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Jing Ding    0371-65588251      
Sponsors and Collaborators
Henan Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: YaoWeitao, Deputy Director, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03163381    
Other Study ID Numbers: AHEAD-HNP007
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Temporarily not sure whether to be Shared the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YaoWeitao, Henan Cancer Hospital:
first-line treatment failure
one measurable lesion
Additional relevant MeSH terms:
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Sarcoma
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action