Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian Cancer

Inclusion Criteria

• •Signed informed consent before undertaking any study procedure.
• •Female, age 18-70.
• •Histologically confirmed FIGO stage III or IV non-mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• •No limitation of the BRCA mutation and HRD status.
• •Platinum resistant or refractory recurrent disease.
• •Subjects must have received at least 1 prior line of platinum-based chemotherapy regimen and no more than twice.
• •Subjects must have measurable lesions with imaging evidence of disease progression (according to RECIST1.1 criteria); or without measurable/evaluable lesion (RECIST 1.1 criteria), but two consecutive cases of elevated CA125 \> 2 times the upper limit of normal (\> 70 U/ml) were detected.
• •Life expectancy of more than 6 months.
• •ECOG 0-1.
• •Good organ function, including:
• •* Bone marrow function: neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥10 g/dL;
• •* Hepatic function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or direct bilirubin ≤1.0 x ULN, AST and ALT ≤2.5 x ULN unless liver metastases are present, in which case they must be ≤5 x ULN;
• •* Renal function: serum creatinine ≤1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation.
• •Has a negative serum pregnancy test within 3 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 3 months after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
• •* ≥45 years and \<60 years of age and has not had menses for \>1 year
• •* ≥60 years of age
• •* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
• •Is able to adhere to the protocol.
• •Has recovered from previous chemotherapy induced toxic side effects to ≤ grade 1 CTCAE or basal level, apart from ≤ grade 2 CTCAE peripheral neuropathy or hair loss symptoms at steady state.