Niraparib is an oral, potent and highly selective PARP1/2 inhibitor. It can be used as a single drug in HRD positive ovarian cancer patients for multi-line therapy. Bevacizumab is a recombinant humanized monoclonal antibody that inhibits tumor angiogenesis and is also recommended for the treatment of recurrent ovarian cancer. Clinical studies showed that niraparib combined with bevacizumab could significantly prolong progression free survival of platinum sensitive recurrent ovarian cancer. We intend to conduct a single-arm, prospective, open-label, phase II study to observe the efficacy and safety of niraparib combined with bevacizumab in the treatment of FIGO III/IV platinum refractory/resistant ovarian cancer, fallopian tube cancer and primary peritoneal cancer. The results are expected to provide more effective and precise treatment for platinum resistant recurrent/refractory ovarian cancer patients.
The study is a single-arm, prospective, open-label, phase II study to observe the efficacy and safety of niraparib combined with bevacizumab in the treatment of FIGO III/IV platinum refractory/resistant ovarian cancer, fallopian tube cancer and primary peritoneal cancer.The primary end point is the objective response rate, and the secondary end points are progression free survival, duration of remission, disease control rate and safety. We also stratified analysis the level of tumor load, the status of BRCA and HRD on the efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Niraparib will be administered orally once a day continuously throughout each 21-days cycle. The initial dose will be based on the participant's basal body weight or platelet count. Participants with basal body weight≥77 kg and basal platelet count of≥150,000/microliter (μL) will take 300 mg daily. While participants with basal body weight\<77 kg and/or basal platelet count \<150,000/μL will take 200 mg daily.
The dose of Bevacizumab will be 15 mg/kg that administered via a 30-minute intravenous infusion on day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death.
JiangSu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGOverall Response Rate (ORR)
ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
Time frame: at 6 months
Progression Free Survival (PFS)
PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.
Time frame: Through study completion, an average of 1 year
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.
Time frame: at 6 months
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
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants.
Time frame: Through study completion, an average of 1 year
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