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Clinical Trial Summary

To evaluate the efficacy and safety of niraparib combined with oral etoposide in platinum resistant or platinum refractory recurrent ovarian cancer.


Clinical Trial Description

This is a single arm, prospective, multicenter, phase II study to evaluate the efficacy and safety of PARP inhibitor niraparib combined with oral etoposide chemotherapy in women with platinum resistant or refractory recurrent ovarian cancer. Subjects will receive niraparib and oral etoposide in 30-day treatment cycles. After 6-8 cycles, oral etoposide will be discontinued. Subjects will receive niraparib alone until disease progression, intolerable toxicity or withdrawal of informed consent. The primary endpoint is progression free survival evaluated by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Secondary endpoints include overall response rate , duration of response, disease control rate, CA125 response rate and safety. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04217798
Study type Interventional
Source Peking Union Medical College Hospital
Contact Jiaxin Yang, MD
Phone 13661160998
Email yangjiaxin@pumch.cn
Status Recruiting
Phase Phase 2
Start date May 21, 2020
Completion date June 1, 2022

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