Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in
participants with Stage III or IV ovarian cancer. Participants must have completed front-line
platinum based regimen with complete response (CR) or partial response (PR). Data collection
for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7
years.
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Gynecologic Cancer
Enrollment Eligibility
Inclusion criteria:
- Participants must have histologically diagnosed high-grade serous or endometrioid, or
high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer,
or primary peritoneal cancer that is Stage III or IV according to Federation
Internationale de Gynécologie et d'Obstétrique (FIGO) criteria.
- Participants with inoperable Stage III and IV disease; All Stage IV participants with
operable disease; Participants with stage III or IV disease treated with neoadjuvant
chemotherapy and interval debulking surgery; and Participants with stage III disease
who have visible residual disease after primary debulking surgery.
- Participants who have received intraperitoneal chemotherapy; All participants must
have had more than or equal to (>=)6 and less than or equal to (<=)9 cycles of
platinum-based therapy; Participants must have had >=2 post-operative cycles of
platinum-based therapy following interval debulking surgery; Participants must have
physician assessed Complete response (CR) or Partial response (PR) after >=3 cycles of
therapy; and Participants must have either Cancer antigen 125 (CA-125) in the normal
range or CA-125 decrease by more than 90 percent(%) during their front-line therapy
that is stable for at least 7 days (no increase more than (>)15% from nadir).
- Participants must be randomized within 12 weeks of the first day of the last cycle of
chemotherapy.
- All participants must agree to undergo central tumor HRD testing.
- Participants of childbearing potential must have a negative serum or urine pregnancy
test (beta human chorionic gonadotropin [hCG]) within 7 days prior to receiving the
first dose of study treatment.
Exclusion criteria:
- Participant has mucinous or clear cell subtypes of epithelial ovarian cancer,
carcinosarcoma or undifferentiated ovarian cancer.
- Participants with Stage III disease who have had complete cytoreduction (no visible
residual disease) after primary debulking surgery.
- Participant has undergone more than two debulking surgeries for the study disease.
- Participant is pregnant, breastfeeding, or expecting to conceive children while
receiving study treatment and for up to 180 days after the last dose of study
treatment.
- Participant has a known hypersensitivity to the components of niraparib or its
excipients.
- Participant has received prior treatment with a known PARP inhibitor or has
participated in a study where any treatment arm included administration of a known
PARP inhibitor.
- Participant is to receive bevacizumab as maintenance treatment.
- Participant has had investigational therapy administered within 4 weeks, or within a
time interval less than at least 5 half-lives of the investigational agent, whichever
is longer, prior to the first scheduled day of dosing in this study.
- Participant has had any known >=Grade 3 anemia, neutropenia or thrombocytopenia due to
prior chemotherapy that persisted >4 weeks.
- Participant has a condition (such as transfusion dependent anemia or
thrombocytopenia), therapy, or laboratory abnormality that might confound the study
results or interfere with the participation for the full duration of the study
treatment, including:
1. Participant received a transfusion (platelets or red blood cells) within 2 weeks
of the first dose of study treatment.
2. Participant received colony-stimulating factors (e.g., granulocyte colony
stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor
[GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of
study treatment.
- Participant has been diagnosed and/or treated for invasive cancer less than 5 years
prior to study enrollment.