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.
- Diseases
- Ovarian cancer
- 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
Sites (109)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Frauenfeld | Switzerland | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Completed |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| KEM I Evang. Kliniken Essen-Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Klinikum Fuerth Anstalt des Oeffentlichen Rechts der Stadt Fuerth Coordinator of this site? Confirm its status | Fuerth | Germany | Completed |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH Coordinator of this site? Confirm its status | Ludwigshafen Am Rhein | Germany | Completed |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Completed |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Completed |
| Hospital Universitari de Girona Doctor Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Completed |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Completed |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Completed |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Completed |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Blackburn | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Portsmouth | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Completed |
| University Hospital Galway Coordinator of this site? Confirm its status | Galway | Ireland | Completed |
| University Hospital Waterford Coordinator of this site? Confirm its status | Waterford | Ireland | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Completed |
| Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Karolinska Institutet Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Covington | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Geneva | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kennewick | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Neptune City | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Willow Grove | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.