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Apatinib for Advanced Osteosarcoma After Failure of Standard Multimodal Therapy

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ClinicalTrials.gov Identifier: NCT02711007
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
GUO WEI, Peking University People's Hospital

Brief Summary:
After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Patients >16 years, progressing after standard treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months and objective response rate (ORR). Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety.

Condition or disease Intervention/treatment Phase
Osteosarcoma Metastasis Drug: apatinib Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Apatinib in Relapsed and Unresectable High-grade Osteosarcoma After Failure of Standard Multimodal Therapy
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : January 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: apatinib
apatinib 750mg tablet or 500mg tablet by mouth, Qd half an hour after dinner
Drug: apatinib
Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.




Primary Outcome Measures :
  1. Progression-free survival, PFS [ Time Frame: 4 months ]
    calculated from the date of treatment start until the time of disease progression or death, whichever comes first.

  2. Objective response rate, ORR [ Time Frame: 3 months ]
    CR+PR at 3 months


Secondary Outcome Measures :
  1. Overall survival, OS [ Time Frame: 12 months ]
    calculated from the date of treatment start until last follow-up or death, whichever comes first.

  2. Clinical benefit rate, CBR [ Time Frame: 6 months ]
    CR+PR+SD at 6 months

  3. Duration of response, DOR [ Time Frame: 6 months ]
    Duration of response is calculated from the day of first response assessment until either progression/death (event) or last day of follow-up (censored).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >16 years;
  • diagnosis confirmed histologically and reviewed centrally;
  • prior treatment (completed >4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high- dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
  • Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy >3 months;
  • adequate renal, hepatic, and hemopoietic function;
  • normal or controlled blood pressure;
  • surgery and/or radiotherapy completion at least 1 month before enrollment.

Exclusion Criteria:

  • no pulmonary artery or venous tumor embolus;
  • previously exposed to other TKIs;
  • central nervous system metastasis;
  • have had other kinds of malignant tumors at the same time;
  • cardiac insufficiency or arrhythmia;
  • uncontrolled complications, such as diabetes mellitus and so on;
  • coagulation disorders;
  • urine protein≥ ++;
  • pleural or peritoneal effusion that needs to be handled by surgical treatment;
  • combined with other infections or wounds.

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): NCT02711007


Locations
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China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
GUO WEI
Investigators
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Study Chair: Wei Guo, M.D. Ph.D. Chinese Medical Association--Sarcoma group
  Study Documents (Full-Text)

Documents provided by GUO WEI, Peking University People's Hospital:
Study Protocol  [PDF] March 1, 2016
Statistical Analysis Plan  [PDF] March 1, 2016

Publications:

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Responsible Party: GUO WEI, The Director of the Musculoskeletal Tumor Center of Peking University People's Hospital and the Principal Investigator of this study, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02711007    
Other Study ID Numbers: PKUPH-sarcoma
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the investigator decide to share all the statistical analysis plan, clinical study report and anlytic code to other researchers
Keywords provided by GUO WEI, Peking University People's Hospital:
osteosarcoma
metastasis
advanced
apatinib
Additional relevant MeSH terms:
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Neoplasm Metastasis
Osteosarcoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action