To evaluate the efficacy and safety of niraparib combined with oral etoposide in platinum resistant or platinum refractory recurrent ovarian cancer.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Subjects will receive niraparib combined with oral etoposide (on day 1-20, every 30 days). After 6-8 cycles, oral etoposide will be terminated. Niraparib will be still given to subjects until disease progression, intolerable toxicity or withdrawal of informed consent.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGShandong Cancer Hospital
Jinan, China
RECRUITINGProgression Free Survival (PFS)
PFS is defined as the time from randomization to first disease progression by investigator assessment using RECIST 1.1 or death, from any cause, whichever comes first.
Time frame: Through study completion, an average of 1 year
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects who have a partial response (PR) or complete response (CR) to therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Through study completion, an average of 1 year
Duration of Response (DOR)
DOR is defined as the time from the first date of response until the date of first documented progression.
Time frame: Through study completion, an average of 1 year
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects who have a complete response (CR), partial response (PR) and stable disease (SD) to therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Through study completion, an average of 1 year
CA125 Response Rate
The proportion of subjects with a minimum 50% reduction in CA-125 serum levels lasting for ≥28 days relative to baseline CA-125 serum levels.
Time frame: Through study completion, an average of 1 year
The frequency and severity of adverse events
The frequency and severity of adverse events evaluated according to NCI CTCAE version 5.0 during subjects receiving the study treatment.
Time frame: Through study completion, an average of 1 year
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