Actively Recruiting
Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
Led by Peking University Cancer Hospital & Institute · Updated on 2023-11-21
116
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open-label, single-arm phase II clinical trial investigating the efficacy and safety of niraparib monotherapy maintenance in HRD-positive newly diagnosed advanced epithelial ovarian cancer (EOC), including primary peritoneal and/or fallopian tube tumors, following response to front-line chemotherapy in combination with bevacizumab. A total of 116 patients will be enrolled.
CONDITIONS
Official Title
Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Female participants aged 18 years or older
- Histologically confirmed primary high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma
- FIGO stage III or IV disease
- Underwent primary or interval tumor reductive surgery
- Received at least 2 cycles of bevacizumab with platinum-based chemotherapy prior to enrollment
- Completed front-line platinum-based chemotherapy with complete response, partial response, or no evidence of disease by RECIST v1.1
- Normal CA-125 levels or a decrease of more than 90% during front-line therapy stable for at least 7 days
- First study treatment dose within 12 weeks of last chemotherapy cycle
- Tumor genetic testing indicating HRD positive or germline/somatic BRCA mutation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate organ function with specified blood counts and liver and kidney function tests within defined limits
You will not qualify if you...
- Histopathological types other than high-grade ovarian/tubal/peritoneal cancer or metastatic ovarian cancer
- Use of other targeted maintenance therapy drugs except PARP inhibitors
- Severe respiratory or blood disorders, uncontrolled diabetes, uncontrolled hypertension grade 2 or higher
- NYHA Class III or higher congestive heart failure, unstable angina, recent myocardial infarction within 6 months, or other serious heart diseases
- Other significant organ complications or impairments affecting safety or drug evaluation
- Expected survival less than 3 months
- Diagnosis of a second primary tumor other than ovarian cancer within the past 2 years and currently under treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
H
Hong Zheng, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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