A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT ID: NCT02655016
Last Updated: 2025-10-08
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
733 participants
INTERVENTIONAL
2016-07-11
2026-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Participants receiving Niraparib
Niraparib
Niraparib will be administered.
Participants receiving Placebo
Placebo
Placebo will be administered.
Interventions
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Niraparib
Niraparib will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
FEMALE
No
Sponsors
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Gynecologic Oncology Group
NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Myriad Genetics, Inc.
INDUSTRY
Tesaro, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Tempe, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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Santa Rosa, California, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Geneva, Illinois, United States
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Hinsdale, Illinois, United States
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Warrenville, Illinois, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Baton Rouge, Louisiana, United States
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Covington, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Burlington, Massachusetts, United States
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Springfield, Massachusetts, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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Springfield, Missouri, United States
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Springfield, Missouri, United States
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Middletown, New Jersey, United States
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Neptune City, New Jersey, United States
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Teaneck, New Jersey, United States
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Buffalo, New York, United States
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Harrison, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Wilmington, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Mayfield Hts, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Austin, Texas, United States
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Fort Worth, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Kennewick, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Bonheiden, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Leuven, , Belgium
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Libramont, , Belgium
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Namur, , Belgium
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Sint-Niklaas, , Belgium
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Calgary, Alberta, Canada
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Ostrava, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Copenhagen, , Denmark
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Herlev, , Denmark
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Odense C, , Denmark
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Kuopio, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Turku, , Finland
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Angers, , France
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Caen, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Pierre-Bénite, , France
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Rennes, , France
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Saint-Herblain, , France
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Aachen, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Essen, , Germany
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Fürth, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Hildesheim, , Germany
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Mannheim, , Germany
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München, , Germany
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München, , Germany
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Debrecen, , Hungary
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Győr, , Hungary
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Dublin, , Ireland
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Dunmore RoadWaterford, , Ireland
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Galway, , Ireland
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Beersheba, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Holon, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Candiolo, , Italy
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Lecce, , Italy
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Milan, , Italy
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Milan, , Italy
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Mirano VE, , Italy
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Modena, , Italy
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Napoli, , Italy
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Oslo, , Norway
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Lublin, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Arkhangelsk, , Russia
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Chelyabinsk, , Russia
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Irkutsk, , Russia
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Ivanovo, , Russia
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Kazan', , Russia
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Krasnoyarsk, , Russia
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Orenburg, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Donostia / San Sebastian, , Spain
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Elche Alicante, , Spain
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Girona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Stockholm, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Bern, , Switzerland
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Frauenfeld, , Switzerland
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Zurich, , Switzerland
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Dnipropetrovsk, , Ukraine
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Dnipropetrovsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kherson, , Ukraine
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Kryvyi Rih, , Ukraine
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Kyiv, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
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Bath, , United Kingdom
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Blackburn, , United Kingdom
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Edinburgh, , United Kingdom
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Exeter, , United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
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Portsmouth, , United Kingdom
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Sheffield, , United Kingdom
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Staffordshire, , United Kingdom
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Truro, , United Kingdom
Countries
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References
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Monk BJ, Barretina-Ginesta MP, Pothuri B, Vergote I, Graybill W, Mirza MR, McCormick CC, Lorusso D, Moore RG, Freyer G, O'Cearbhaill RE, Heitz F, O'Malley DM, Redondo A, Shahin MS, Vulsteke C, Bradley WH, Haslund CA, Chase DM, Pisano C, Holman LL, Perez MJR, DiSilvestro P, Gaba L, Herzog TJ, Bruchim I, Compton N, Shtessel L, Malinowska IA, Gonzalez-Martin A. Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Ann Oncol. 2024 Nov;35(11):981-992. doi: 10.1016/j.annonc.2024.08.2241. Epub 2024 Sep 14.
Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AO, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, Gonzalez-Martin A. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer. Clin Ther. 2024 Aug;46(8):612-621. doi: 10.1016/j.clinthera.2024.06.001. Epub 2024 Jul 16.
Vulsteke C, Chambers SK, Perez MJR, Chan JK, Raaschou-Jensen N, Zhuo Y, Lorusso D, Herzog TJ, de la Motte Rouge T, Thomes Pepin JA, Braicu EI, Chen LM, Levy T, Barter JF, Pilar Barretina-Ginesta M, Joosens E, York W, Malinowska IA, Gonzalez-Martin A, Monk BJ. Tolerability of the niraparib individualized starting dose in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy. Eur J Cancer. 2024 Sep;208:114157. doi: 10.1016/j.ejca.2024.114157. Epub 2024 Jun 10.
Graybill WS, Pardo Burdalo B, O'Malley DM, Vergote I, Monk BJ, Auranen A, Copeland LJ, Sabbatini R, Herzog TJ, Follana P, Pothuri B, Braicu EI, McCormick C, Yubero A, Moore RG, Vuylsteke P, Raaschou-Jensen N, York W, Hartman J, Gonzalez-Martin A. Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study. Int J Gynecol Cancer. 2024 Jul 1;34(7):1041-1050. doi: 10.1136/ijgc-2024-005356.
Valabrega G, Pothuri B, Oaknin A, Graybill WS, Sanchez AB, McCormick C, Baurain JF, Tinker AV, Denys H, O'Cearbhaill RE, Hietanen S, Moore RG, Knudsen AO, de La Motte Rouge T, Heitz F, Levy T, York W, Gupta D, Monk BJ, Gonzalez-Martin A. Efficacy and safety of niraparib in patients aged 65 years and older with advanced ovarian cancer: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Gynecol Oncol. 2024 Aug;187:128-138. doi: 10.1016/j.ygyno.2024.03.009. Epub 2024 Jun 3.
Gonzalez-Martin A, Pothuri B, Vergote I, Graybill W, Lorusso D, McCormick CC, Freyer G, Backes F, Heitz F, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Malinowska IA, Shtessel L, Compton N, Mirza MR, Monk BJ. Progression-free survival and safety at 3.5 years of follow-up: results from the randomized phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer - a plain language summary. Future Oncol. 2024;20(22):1531-1544. doi: 10.2217/fon-2023-0782. Epub 2024 Mar 19.
Pothuri B, Han S, Chase DM, Heitz F, Burger RA, Gaba L, Van Le L, Guerra E, Bender D, Korach J, Cloven N, Churruca C, Follana P, DiSilvestro P, Baurain JF, Jardon K, Pisano C, Peen U, Maenpaa J, Gupta D, Bacque E, Li Y, Compton N, Antonova J, Monk BJ, Gonzalez-Martin A. Health-related quality of life in patients with newly diagnosed advanced ovarian cancer treated with niraparib vs placebo: Results from the phase 3 randomized PRIMA/ENGOT-OV26/GOG-3012 trial. Gynecol Oncol. 2024 May;184:168-177. doi: 10.1016/j.ygyno.2024.01.021. Epub 2024 Feb 6.
Gonzalez-Martin A, Pothuri B, Vergote I, Graybill W, Lorusso D, McCormick CC, Freyer G, Backes F, Heitz F, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Malinowska IA, Shtessel L, Compton N, Mirza MR, Monk BJ. Progression-free survival and safety at 3.5years of follow-up: results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer. Eur J Cancer. 2023 Aug;189:112908. doi: 10.1016/j.ejca.2023.04.024. Epub 2023 May 3.
Barretina-Ginesta MP, Monk BJ, Han S, Pothuri B, Auranen A, Chase DM, Lorusso D, Anderson C, Abadie-Lacourtoisie S, Cloven N, Braicu EI, Amit A, Redondo A, Shah R, Kebede N, Hawkes C, Gupta D, Woodward T, O'Malley DM, Gonzalez-Martin A. Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial. Ther Adv Med Oncol. 2022 Sep 22;14:17588359221126149. doi: 10.1177/17588359221126149. eCollection 2022.
O'Cearbhaill RE, Perez-Fidalgo JA, Monk BJ, Tusquets I, McCormick C, Fuentes J, Moore RG, Vulsteke C, Shahin MS, Forget F, Bradley WH, Hietanen S, O'Malley DM, Dorum A, Slomovitz BM, Baumann K, Selle F, Calvert PM, Artioli G, Levy T, Kumar A, Malinowska IA, Li Y, Gupta D, Gonzalez-Martin A. Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study. Gynecol Oncol. 2022 Jul;166(1):36-43. doi: 10.1016/j.ygyno.2022.04.012. Epub 2022 May 9.
Gonzalez-Martin A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Perez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PR-30-5017-C
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508010-42
Identifier Type: OTHER
Identifier Source: secondary_id
213359
Identifier Type: -
Identifier Source: org_study_id
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