Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
Recruiting
Phase 2Interventional Study
Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
116 (estimated)
Sponsor
Peking University Cancer Hospital & Institute · Other
Who this trial is looking for
This trial is looking for women with advanced ovarian cancer who have had successful initial treatment. Participants will receive a medication called niraparib to help maintain their cancer's response after treatment.
Are You a Good Fit for This Trial?
Must be takingBevacizumab
You may be able to join if
I am a woman aged 18 or older
I have been diagnosed with advanced ovarian cancer
I have completed front-line chemotherapy with a good response
I received a minimum of 2 cycles of bevacizumab with chemotherapy
I have HRD positive cancer or a BRCA mutation
I have normal organ function based on specific tests
I can start treatment within 12 weeks of my last chemotherapy
I have signed the consent form to join the trial
You may not be able to join if
I have a different type of cancer besides ovarian cancer
I have severe respiratory or blood disorders
I have uncontrolled high blood pressure
I have had a heart attack in the past 6 months
I have significant other health issues that might affect my safety
I am expected to live less than 3 months
I have been diagnosed with another cancer in the past 2 years
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 enrol…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. The written informed consent form shall be signed before proceeding with any study-related procedure.
2. Participants shall be a female, aged 18 years or older.
3. Histologically confirmed primary high-grade epithelial ovarian cancer, fallopian tube carcinoma or primary perit…
Inclusion Criteria:
1. The written informed consent form shall be signed before proceeding with any study-related procedure.
2. Participants shall be a female, aged 18 years or older.
3. Histologically confirmed primary high-grade epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma。
4. FIGO staging is Stage III or IV.
5. Patients who have undergone primary tumor reductive surgery or intermittent tumor reductive surgery (patients who have used neoadjuvant therapy), regardless of postoperative residual lesion status
6. Participants must have received, prior to enrollment, a minimum of 2 cycles of bevacizumab in combination with platinum-based chemotherapy.
7. Participants must have completed front-line, platinum-based chemotherapy with CR, PR, or NED assessed by RECIST v1.1.
8. Participant must have either CA-125 in the normal range or CA-125 decrease by more than 90% during front-line therapy that is stable for at least 7 days (ie, no increase \> 15% from nadir).
9. Participants must have first study treatment dose within 12 weeks of the first day of the last cycle of chemotherapy.
10. Genetic testing of tumor tissue indicates HRD positive or germline/somatic BRCA mutation prior to enrollment.
11. Participant must have an Eastern Cooperative Oncology Group (ECOG) score ≤2.
12. Organ function is in good condition, including: Hemoglobin ≥100 g/L; White blood cell count ≥3×10\^9/L; Neutrophil count ≥1.5×10\^9/L; Platelet count ≥100×10\^9/L; Total bilirubin is not more than 1.5 times the normal upper limit; ALK, AST and ALT are not more than 2.5 times their normal upper limit, and with existence of hepatic metastasis, these values must not be more than 5 times their normal upper limit; Serum creatinine is not more than 1.5 times the normal upper limit.
Exclusion Criteria:
1. Histopathological types other than high-grade ovarian/tubal/peritoneal cancer or metastatic ovarian cancer.
2. Receipt of other targeted drugs as maintenance therapy, excluding PARP inhibitors.
3. Concurrent severe respiratory or hematologic disorders, poorly controlled diabetes, uncontrolled hypertension of Grade 2 or higher, NYHA Class III or higher congestive heart failure, unstable angina, recent myocardial infarction within the past 6 months, or other circulatory system diseases.
4. Any other significant complications or functional impairments in organ systems, as determined by the investigator, that may affect the safety of the participant or interfere with the evaluation of the investigational drug.
5. Expected survival less than 3 months.
6. Other than ovarian cancer, the participant has been diagnosed a second primary tumor within the past 2 years and currently undergoing treatment.
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