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NCT02655016Active, not recruitingPhase 3

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Source: ClinicalTrials.gov · Last updated 10 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
733 (actual)
First submitted
8 Dec 2015
Start date
11 Jul 2016
Primary completion date
17 May 2019
Lead sponsor
Tesaro, Inc.
NCT number
NCT02655016
EU CT number
2023-508010-42-00
EudraCT number
2015-000952-11

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 733
  • From 11 Jul 2016 to the primary completion date, 17 May 2019
  • 109 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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 been diagnosed and/or treated for invasive cancer less than 5 years prior to study enrollment.

Other illness

  • 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 has a known hypersensitivity to the components of niraparib or its excipients.

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (109)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Saint-Pierre
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BrusselsBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
Az Maria Middelares Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Vitaz
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Sint-NiklaasBelgiumCompleted
GSK Investigational Site
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BaselSwitzerlandUnknown status
GSK Investigational Site
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BernSwitzerlandUnknown status
GSK Investigational Site
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FrauenfeldSwitzerlandUnknown status
GSK Investigational Site
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ZurichSwitzerlandUnknown status
Fakultni Nemocnice Plzen
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Plzen 3CzechiaCompleted
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyCompleted
Klinikum Fuerth Anstalt des Oeffentlichen Rechts der Stadt Fuerth
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FuerthGermanyCompleted
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
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Ludwigshafen Am RheinGermanyCompleted
Aalborg University Hospital
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AalborgDenmarkCompleted
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Region Hovedstaden
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HerlevDenmarkCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Institut Catala d'Oncologia
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BadalonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Hospital General Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitario Donostia
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DonostiaSpainCompleted
Hospital General Universitario de Elche
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ElcheSpainCompleted
Hospital Universitari de Girona Doctor Josep Trueta
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GironaSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
MD Anderson Cancer Center
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Fundación Instituto Valenciano de Oncología
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ValenciaSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted
Kuopio University Hospital
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KuopioFinlandCompleted
Turku University Hospital
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TurkuFinlandCompleted
Institut de Cancerologie de L'Ouest
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AngersFranceCompleted
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceCompleted
Centre Antoine Lacassagne
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Nice Cedex 2FranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Centre De Lutte Contre Le Cancer Eugene Marquis
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Rennes CedexFranceCompleted
GSK Investigational Site
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BlackburnUnited KingdomUnknown status
GSK Investigational Site
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EdinburghUnited KingdomUnknown status
GSK Investigational Site
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ExeterUnited KingdomUnknown status
GSK Investigational Site
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GlasgowUnited KingdomUnknown status
GSK Investigational Site
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LondonUnited KingdomUnknown status
GSK Investigational Site
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PortsmouthUnited KingdomUnknown status
GSK Investigational Site
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SheffieldUnited KingdomUnknown status
GSK Investigational Site
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TruroUnited KingdomUnknown status
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryCompleted
University Hospital Galway
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GalwayIrelandCompleted
University Hospital Waterford
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WaterfordIrelandCompleted
GSK Investigational Site
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HaifaIsraelUnknown status
GSK Investigational Site
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Ramat GanIsraelUnknown status
GSK Investigational Site
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Tel AvivIsraelUnknown status
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
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CandioloItalyCompleted
Istituto Nazionale dei Tumori
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MilanItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyCompleted
GSK Investigational Site
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OsloNorwayUnknown status
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandCompleted
Karolinska Institutet
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SolnaSwedenCompleted
GSK Investigational Site
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AtlantaUnited StatesUnknown status
GSK Investigational Site
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BaltimoreUnited StatesUnknown status
GSK Investigational Site
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BurlingtonUnited StatesUnknown status
GSK Investigational Site
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Chapel HillUnited StatesUnknown status
GSK Investigational Site
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CharlestonUnited StatesUnknown status
GSK Investigational Site
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ColumbusUnited StatesUnknown status
GSK Investigational Site
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CovingtonUnited StatesUnknown status
GSK Investigational Site
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Fort WorthUnited StatesUnknown status
GSK Investigational Site
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GenevaUnited StatesUnknown status
GSK Investigational Site
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Grand RapidsUnited StatesUnknown status
GSK Investigational Site
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HarrisonUnited StatesUnknown status
GSK Investigational Site
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IndianapolisUnited StatesUnknown status
GSK Investigational Site
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Iowa CityUnited StatesUnknown status
GSK Investigational Site
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JacksonvilleUnited StatesUnknown status
GSK Investigational Site
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KennewickUnited StatesUnknown status
GSK Investigational Site
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MiamiUnited StatesUnknown status
GSK Investigational Site
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MilwaukeeUnited StatesUnknown status
GSK Investigational Site
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MineolaUnited StatesUnknown status
GSK Investigational Site
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MinneapolisUnited StatesUnknown status
GSK Investigational Site
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Neptune CityUnited StatesUnknown status
GSK Investigational Site
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New HavenUnited StatesUnknown status
GSK Investigational Site
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New OrleansUnited StatesUnknown status
GSK Investigational Site
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New YorkUnited StatesUnknown status
GSK Investigational Site
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Oklahoma CityUnited StatesUnknown status
GSK Investigational Site
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PhiladelphiaUnited StatesUnknown status
GSK Investigational Site
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PortlandUnited StatesUnknown status
GSK Investigational Site
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ProvidenceUnited StatesUnknown status
GSK Investigational Site
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RochesterUnited StatesUnknown status
GSK Investigational Site
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RockvilleUnited StatesUnknown status
GSK Investigational Site
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Salt Lake CityUnited StatesUnknown status
GSK Investigational Site
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San FranciscoUnited StatesUnknown status
GSK Investigational Site
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Santa RosaUnited StatesUnknown status
GSK Investigational Site
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SavannahUnited StatesUnknown status
GSK Investigational Site
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SeattleUnited StatesUnknown status
GSK Investigational Site
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Sioux FallsUnited StatesUnknown status
GSK Investigational Site
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SpokaneUnited StatesUnknown status
GSK Investigational Site
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SpringfieldUnited StatesUnknown status
GSK Investigational Site
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TempeUnited StatesUnknown status
GSK Investigational Site
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The WoodlandsUnited StatesUnknown status
GSK Investigational Site
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TucsonUnited StatesUnknown status
GSK Investigational Site
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TulsaUnited StatesUnknown status
GSK Investigational Site
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TylerUnited StatesUnknown status
GSK Investigational Site
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Willow GroveUnited StatesUnknown status
GSK Investigational Site
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WilmingtonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.