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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

733

Study ID:

NCT02655016

Recruitment Status:

Active, not recruiting

Sponsor:

Tesaro, Inc.

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There are 196 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

733

Study ID:

NCT02655016

Recruitment Status:

Active, not recruiting

Sponsor:


Tesaro, Inc.

How clear is this clinincal trial information?

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