Last updated: November 15, 2023
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
Niraparib
Clinical Study ID
NCT06141265
2023YJZ62
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The written informed consent form shall be signed before proceeding with anystudy-related procedure.
- Participants shall be a female, aged 18 years or older.
- Histologically confirmed primary high-grade epithelial ovarian cancer, fallopian tubecarcinoma or primary peritoneal carcinoma。
- FIGO staging is Stage III or IV.
- Patients who have undergone primary tumor reductive surgery or intermittent tumorreductive surgery (patients who have used neoadjuvant therapy), regardless ofpostoperative residual lesion status
- Participants must have received, prior to enrollment, a minimum of 2 cycles ofbevacizumab in combination with platinum-based chemotherapy.
- Participants must have completed front-line, platinum-based chemotherapy with CR, PR,or NED assessed by RECIST v1.1.
- Participant must have either CA-125 in the normal range or CA-125 decrease by morethan 90% during front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir).
- Participants must have first study treatment dose within 12 weeks of the first day ofthe last cycle of chemotherapy.
- Genetic testing of tumor tissue indicates HRD positive or germline/somatic BRCAmutation prior to enrollment.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) score ≤2.
- Organ function is in good condition, including: Hemoglobin ≥100 g/L; White blood cellcount ≥3×10^9/L; Neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Totalbilirubin is not more than 1.5 times the normal upper limit; ALK, AST and ALT are notmore than 2.5 times their normal upper limit, and with existence of hepaticmetastasis, these values must not be more than 5 times their normal upper limit; Serumcreatinine is not more than 1.5 times the normal upper limit.
Exclusion
Exclusion Criteria:
- Histopathological types other than high-grade ovarian/tubal/peritoneal cancer ormetastatic ovarian cancer.
- Receipt of other targeted drugs as maintenance therapy, excluding PARP inhibitors.
- Concurrent severe respiratory or hematologic disorders, poorly controlled diabetes,uncontrolled hypertension of Grade 2 or higher, NYHA Class III or higher congestiveheart failure, unstable angina, recent myocardial infarction within the past 6 months,or other circulatory system diseases.
- Any other significant complications or functional impairments in organ systems, asdetermined by the investigator, that may affect the safety of the participant orinterfere with the evaluation of the investigational drug.
- Expected survival less than 3 months.
- Other than ovarian cancer, the participant has been diagnosed a second primary tumorwithin the past 2 years and currently undergoing treatment.
Study Design
Total Participants: 116
Treatment Group(s): 1
Primary Treatment: Niraparib
Phase: 2
Study Start date:
November 01, 2023
Estimated Completion Date:
September 30, 2027
Connect with a study center
Peking University Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting

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