| Eligibility |
Inclusion Criteria:
1. Participant has histologically confirmed diagnosis of FGIO stage III-IV high-grade
serous or high-grade endometrioid ovarian cancer, primary peritoneal cancer, or
fallopian tube cancer will be enrolled in this study.
2. Participant has confirmed as both germline and somatic BRCA1/2 wild-type by
institution's test.
3. Participant has no visible residual tumor after primary cytoreductive surgery (or
optimally debulked) and has responded to the postoperative platinum-based combination
chemotherapy (complete or partial response), remains in response, and is enrolled on
study within 12 weeks of completion of the last platinum regimen
4. Participant who is able to provide tumor slides obtained during cytoreductive surgery
for a prospective examination of the homologous recombination deficiency (HRD).
5. Female participants who are at least 20 years of age on the day of signing informed
consent with
6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1, as assessed within 10 days prior to enrollment.
7. Participant is eligible to participate if she is not pregnant (see Appendix 2), not
breastfeeding, and at least one of the following conditions applies:
1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR
2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the
treatment period and for at least 180 days following the last dose of niraparib.
8. The participant (or legally acceptable representative if applicable) provides written
informed consent for the trial. The participant may also provide consent for future
biomedical research; however, the participant may participate in the main study
without participating in future biomedical research.
9. Participant has adequate organ function as defined in the following table (Table 1).;
all screening laboratory tests should be performed within 10 days prior to the start
of study treatment.
Exclusion Criteria:
1. Participant has mucinous, germ cell, or borderline tumor of the ovary.
2. Participant receives neoadjuvant chemotherapy before cytoreductive surgery.
3. Participant has a visible residual tumor after primary cytoreductive surgery.
4. Participant receives bevacizumab with front-line platinum-based combination
chemotherapy.
5. Participant has a history of non-infectious pneumonitis that required treatment with
steroids or currently has pneumonitis.
6. Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or
has features suggestive of MDS/AML.
7. Participant has a known additional malignancy that is progressing or has required
active treatment within the past 2 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of
the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ,
endometrial carcinoma) that have undergone potentially curative therapy are not
excluded.
Note: Participants with synchronous primary endometrial cancer or a past history of
primary endometrial cancer that met the following conditions are not excluded: Stage
not greater than IA: no more than superficial myometrial invasion.
8. Drainage of ascites during the last 2 cycles of last chemotherapy.
9. Palliative radiotherapy within 1 week encompassing >20% of the bone marrow.
10. Persistent >grade 2 toxicity from prior cancer therapy.
11. Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the
absence of brain metastases is not required. Patients with spinal cord compression may
be considered if they have received definitive treatment for this and evidence of
clinically stable disease for 28 days.
12. Major surgery within 3 weeks of starting the study or patient has not recovered from
any effects of any major surgery.
13. Patients considered a poor medical risk due to a serious, uncontrolled medical
disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples
include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3
months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal
cord compression, superior vena cava syndrome, or any psychiatric disorder that
prohibits obtaining informed consent.
14. History or current evidence of any condition, therapy, or lab abnormality that might
confound the results of the study, interfere with the patient's participation for the
full duration of the study treatment or is not in the best interest of the patient to
participate.
15. Patient is pregnant or breast feeding, or expecting to conceive children within the
projected duration of the study treatment.
16. Immunocompromised patients.
17. Patients with known active hepatic disease (i.e., Hepatitis B or C).
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