A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression Free Survival — Up to 34 months Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.
Trial sites (116)
Facility
City
Region
Status
GSK Investigational Site
Tempe
Arizona
GSK Investigational Site
Tucson
Arizona
GSK Investigational Site
Tucson
Arizona
GSK Investigational Site
San Francisco
California
GSK Investigational Site
San Francisco
California
GSK Investigational Site
Santa Rosa
California
GSK Investigational Site
New Haven
Connecticut
GSK Investigational Site
Jacksonville
Florida
GSK Investigational Site
Miami
Florida
GSK Investigational Site
Atlanta
Georgia
GSK Investigational Site
Savannah
Georgia
GSK Investigational Site
Geneva
Illinois
GSK Investigational Site
Indianapolis
Indiana
GSK Investigational Site
Indianapolis
Indiana
GSK Investigational Site
Iowa City
Iowa
GSK Investigational Site
Covington
Louisiana
GSK Investigational Site
New Orleans
Louisiana
GSK Investigational Site
Baltimore
Maryland
GSK Investigational Site
Rockville
Maryland
GSK Investigational Site
Burlington
Massachusetts
GSK Investigational Site
Grand Rapids
Michigan
GSK Investigational Site
Minneapolis
Minnesota
GSK Investigational Site
Springfield
Missouri
GSK Investigational Site
Neptune City
New Jersey
GSK Investigational Site
Harrison
New York
GSK Investigational Site
Mineola
New York
GSK Investigational Site
New York
New York
GSK Investigational Site
Rochester
New York
GSK Investigational Site
Chapel Hill
North Carolina
GSK Investigational Site
Wilmington
North Carolina
GSK Investigational Site
Columbus
Ohio
GSK Investigational Site
Oklahoma City
Oklahoma
GSK Investigational Site
Tulsa
Oklahoma
GSK Investigational Site
Portland
Oregon
GSK Investigational Site
Philadelphia
Pennsylvania
GSK Investigational Site
Willow Grove
Pennsylvania
GSK Investigational Site
Providence
Rhode Island
GSK Investigational Site
Charleston
South Carolina
GSK Investigational Site
Sioux Falls
South Dakota
GSK Investigational Site
Fort Worth
Texas
+ 76 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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