Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
NCT ID: NCT06141265
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
116 participants
INTERVENTIONAL
2023-11-01
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Niraparib
The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Niraparib
The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Interventions
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Niraparib
The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Hong Zheng
M.D.
Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023YJZ62
Identifier Type: -
Identifier Source: org_study_id