Apatinib for Advanced Osteosarcoma After Failure of Standard Multimodal Therapy
|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: NCT02711007|
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : April 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma Metastasis||Drug: apatinib||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
apatinib 750mg tablet or 500mg tablet by mouth, Qd half an hour after dinner
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.
- 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.
- Objective response rate, ORR [ Time Frame: 3 months ]CR+PR at 3 months
- Overall survival, OS [ Time Frame: 12 months ]calculated from the date of treatment start until last follow-up or death, whichever comes first.
- Clinical benefit rate, CBR [ Time Frame: 6 months ]CR+PR+SD at 6 months
- 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).
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
|Peking University People's Hospital|
|Beijing, Beijing, China, 100044|
|Study Chair:||Wei Guo, M.D. Ph.D.||Chinese Medical Association--Sarcoma group|