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Trial Title:
Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
NCT ID:
NCT06141265
Condition:
Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Conditions: Official terms:
Niraparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Niraparib
Description:
The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or
baseline platelet count
Arm group label:
Niraparib
Summary:
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.
Criteria for 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 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Hong Zheng, M.D.
Phone:
86-010-88196100
Email:
zhhong306@hotmail.com
Start date:
November 1, 2023
Completion date:
September 2027
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06141265
