Ovarian Cancer Clinical Trial
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
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 (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 Criteria
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:
Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment.
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.
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There are 196 Locations for this study
Mesa Arizona, 85284, United States
Tucson Arizona, 85710, United States
Tucson Arizona, 85724, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
San Francisco California, 94118, United States
Santa Rosa California, 95403, United States
Hartford Connecticut, 06102, United States
New Haven Connecticut, 06510, United States
Hollywood Florida, 33323, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30912, United States
Savannah Georgia, 31404, United States
Chicago Illinois, 60612, United States
Hinsdale Illinois, 60521, United States
Warrenville Illinois, 60555, United States
Indianapolis Indiana, 46237, United States
Indianapolis Indiana, 46260, United States
Iowa City Iowa, 52242, United States
Baton Rouge Louisiana, 70817, United States
Covington Louisiana, 70433, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21215, United States
Silver Spring Maryland, 20910, United States
Burlington Massachusetts, 01805, United States
Springfield Massachusetts, 01199, United States
Grand Rapids Michigan, 49503, United States
Minneapolis Minnesota, 55404, United States
Springfield Missouri, 65807, United States
Middletown New Jersey, 07748, United States
Neptune New Jersey, 07753, United States
Teaneck New Jersey, 07666, United States
Buffalo New York, 14263, United States
Harrison New York, 10604, United States
Mineola New York, 11501, United States
New York New York, 10016, United States
New York New York, 10065, United States
Rochester New York, 14620, United States
Chapel Hill North Carolina, 27599, United States
Wilmington North Carolina, 28401, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44124, United States
Columbus Ohio, 43210, United States
Mayfield Heights Ohio, 44124, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Portland Oregon, 97210, United States
Springfield Oregon, 97477, United States
Philadelphia Pennsylvania, 19104, United States
Willow Grove Pennsylvania, 19090, United States
Providence Rhode Island, 02905, United States
Charleston South Carolina, 29425, United States
Sioux Falls South Dakota, 57105, United States
Austin Texas, 78731, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78229, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75701, United States
Salt Lake City Utah, 84112, United States
Kennewick Washington, 99336, United States
Seattle Washington, 98104, United States
Spokane Washington, 99202, United States
Morgantown West Virginia, 26505, United States
Milwaukee Wisconsin, 53226, United States
Bonheiden , 2820, Belgium
Bruxelles , 1000, Belgium
Bruxelles , 1200, Belgium
Charleroi , 6000, Belgium
Gent , 9000, Belgium
Hasselt , 3500, Belgium
Leuven , 3000, Belgium
Libramont , 6800, Belgium
Namur , 5000, Belgium
Sint-Niklaas , 9100, Belgium
Calgary Alberta, T2N 4, Canada
Kelowna British Columbia, V1Y 5, Canada
Surrey British Columbia, V3V 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Barrie Ontario, L4M 6, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1Y 4, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A 3, Canada
Montréal Quebec, H2X 0, Canada
Brno , 602 0, Czechia
Ostrava , 708 5, Czechia
Plzen-Lochotin , 30460, Czechia
Prague , 10034, Czechia
Prague , 128 5, Czechia
Aalborg , 9000, Denmark
Herlev , 2730, Denmark
Koebenhavn Oe , 2100, Denmark
Odense , 5000, Denmark
Kuopio , 70210, Finland
Oulu , 90029, Finland
Tampere , 33521, Finland
Turku , 20520, Finland
Angers , 49000, France
Caen Cedex 05 , 14076, France
Montpellier Cedex 5 , 34298, France
Nice Cedex 2 , 06189, France
Paris Cedex 15 , 75908, France
Paris , 75020, France
Pierre-Benite cedex , 69495, France
Rennes Cedex , 35042, France
Saint-Herblain , 44805, France
Heidelberg Baden-Wuerttemberg, 69120, Germany
Mannheim Baden-Wuerttemberg, 68167, Germany
Fuerth Bayern, 90766, Germany
Muenchen Bayern, 81377, Germany
Muenchen Bayern, 81737, Germany
Goettingen Niedersachsen, 37075, Germany
Hildesheim Niedersachsen, 31134, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Essen Nordrhein-Westfalen, 45136, Germany
Ludwigshafen Rheinland-Pfalz, 67063, Germany
Dresden Sachsen, 01307, Germany
Berlin , 13353, Germany
Hamburg , 20246, Germany
Debrecen , 4032, Hungary
Gyor , 9024, Hungary
Dublin , 8, Ireland
Galway , H91 Y, Ireland
Waterford , , Ireland
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Haifa , 38100, Israel
Holon , 58100, Israel
Petach Tikva , 49100, Israel
Tel Aviv , 64239, Israel
Tel Hashomer , 52621, Israel
Napoli Campania, 80131, Italy
Modena Emilia-Romagna, 41100, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Candiolo (TO) Piemonte, 10060, Italy
Lecce Puglia, 73100, Italy
Mirano Veneto, 30035, Italy
Oslo , 0310, Norway
Lodz , 93-51, Poland
Lublin , 20-09, Poland
Olsztyn , 10-56, Poland
Poznan , 60-56, Poland
Arkhangelsk , 16304, Russian Federation
Chelyabinsk , 45404, Russian Federation
Irkutsk , 66403, Russian Federation
Ivanovo , 15304, Russian Federation
Kazan , 42002, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Orenburg , 46002, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Samara , 44301, Russian Federation
St-Petersburg , 19401, Russian Federation
St. Petersburg , 19110, Russian Federation
St. Petersburg , 19775, Russian Federation
Badalona , 08916, Spain
Barcelona , 08003, Spain
Barcelona , 08036, Spain
Barcelona , 8035, Spain
Cordoba , 14004, Spain
Elche , 03203, Spain
Girona , 17007, Spain
Hospitalet de Llobregat, Barcelona , 08907, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
San Sebastián , 20014, Spain
Sevilla , 41013, Spain
Sevilla , 41014, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
Zaragoza , 50009, Spain
Stockholm , SE-17, Sweden
Uppsala , SE-75, Sweden
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Frauenfeld , 8501, Switzerland
Zurich , 8091, Switzerland
Dnipropetrovsk , 49102, Ukraine
Dnipro , 49100, Ukraine
Ivano-Frankivsk , 76000, Ukraine
Kharkiv , 61070, Ukraine
Kherson , 73000, Ukraine
Krivoy Rog , 50048, Ukraine
Kyiv , 03022, Ukraine
Vinnitsia , 21029, Ukraine
Zaporizhzhia , 69040, Ukraine
Portsmouth Hampshire, PO6 3, United Kingdom
Bath Somerset, BA1 3, United Kingdom
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
Blackburn , BB2 3, United Kingdom
Exeter , EX2 5, United Kingdom
Glasgow , G12 0, United Kingdom
London , W12 0, United Kingdom
Sheffield , S10 2, United Kingdom
Truro , TR1 3, United Kingdom
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