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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

733 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-11

Study Completion Date

2026-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants receiving Niraparib

Group Type EXPERIMENTAL

Niraparib

Intervention Type DRUG

Niraparib will be administered.

Participants receiving Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Niraparib

Niraparib will be administered.

Intervention Type DRUG

Placebo

Placebo will be administered.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gynecologic Oncology Group

NETWORK

Sponsor Role collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

Sponsor Role collaborator

Myriad Genetics, Inc.

INDUSTRY

Sponsor Role collaborator

Tesaro, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Tempe, Arizona, United States

Site Status

GSK Investigational Site

Tucson, Arizona, United States

Site Status

GSK Investigational Site

Tucson, Arizona, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Santa Rosa, California, United States

Site Status

GSK Investigational Site

Hartford, Connecticut, United States

Site Status

GSK Investigational Site

New Haven, Connecticut, United States

Site Status

GSK Investigational Site

Hollywood, Florida, United States

Site Status

GSK Investigational Site

Jacksonville, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Augusta, Georgia, United States

Site Status

GSK Investigational Site

Savannah, Georgia, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Geneva, Illinois, United States

Site Status

GSK Investigational Site

Hinsdale, Illinois, United States

Site Status

GSK Investigational Site

Warrenville, Illinois, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Iowa City, Iowa, United States

Site Status

GSK Investigational Site

Baton Rouge, Louisiana, United States

Site Status

GSK Investigational Site

Covington, Louisiana, United States

Site Status

GSK Investigational Site

New Orleans, Louisiana, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

Rockville, Maryland, United States

Site Status

GSK Investigational Site

Burlington, Massachusetts, United States

Site Status

GSK Investigational Site

Springfield, Massachusetts, United States

Site Status

GSK Investigational Site

Grand Rapids, Michigan, United States

Site Status

GSK Investigational Site

Minneapolis, Minnesota, United States

Site Status

GSK Investigational Site

Springfield, Missouri, United States

Site Status

GSK Investigational Site

Springfield, Missouri, United States

Site Status

GSK Investigational Site

Middletown, New Jersey, United States

Site Status

GSK Investigational Site

Neptune City, New Jersey, United States

Site Status

GSK Investigational Site

Teaneck, New Jersey, United States

Site Status

GSK Investigational Site

Buffalo, New York, United States

Site Status

GSK Investigational Site

Harrison, New York, United States

Site Status

GSK Investigational Site

Mineola, New York, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Rochester, New York, United States

Site Status

GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Wilmington, North Carolina, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Mayfield Hts, Ohio, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Tulsa, Oklahoma, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Willow Grove, Pennsylvania, United States

Site Status

GSK Investigational Site

Providence, Rhode Island, United States

Site Status

GSK Investigational Site

Charleston, South Carolina, United States

Site Status

GSK Investigational Site

Sioux Falls, South Dakota, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Fort Worth, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

The Woodlands, Texas, United States

Site Status

GSK Investigational Site

Tyler, Texas, United States

Site Status

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status

GSK Investigational Site

Kennewick, Washington, United States

Site Status

GSK Investigational Site

Seattle, Washington, United States

Site Status

GSK Investigational Site

Spokane, Washington, United States

Site Status

GSK Investigational Site

Morgantown, West Virginia, United States

Site Status

GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

GSK Investigational Site

Bonheiden, , Belgium

Site Status

GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Charleroi, , Belgium

Site Status

GSK Investigational Site

Ghent, , Belgium

Site Status

GSK Investigational Site

Hasselt, , Belgium

Site Status

GSK Investigational Site

Leuven, , Belgium

Site Status

GSK Investigational Site

Libramont, , Belgium

Site Status

GSK Investigational Site

Namur, , Belgium

Site Status

GSK Investigational Site

Sint-Niklaas, , Belgium

Site Status

GSK Investigational Site

Calgary, Alberta, Canada

Site Status

GSK Investigational Site

Kelowna, British Columbia, Canada

Site Status

GSK Investigational Site

Surrey, British Columbia, Canada

Site Status

GSK Investigational Site

Vancouver, British Columbia, Canada

Site Status

GSK Investigational Site

Barrie, Ontario, Canada

Site Status

GSK Investigational Site

London, Ontario, Canada

Site Status

GSK Investigational Site

Ottawa, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Ostrava, , Czechia

Site Status

GSK Investigational Site

Pilsen, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Aalborg, , Denmark

Site Status

GSK Investigational Site

Copenhagen, , Denmark

Site Status

GSK Investigational Site

Herlev, , Denmark

Site Status

GSK Investigational Site

Odense C, , Denmark

Site Status

GSK Investigational Site

Kuopio, , Finland

Site Status

GSK Investigational Site

Oulu, , Finland

Site Status

GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Turku, , Finland

Site Status

GSK Investigational Site

Angers, , France

Site Status

GSK Investigational Site

Caen, , France

Site Status

GSK Investigational Site

Montpellier, , France

Site Status

GSK Investigational Site

Nice, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Pierre-Bénite, , France

Site Status

GSK Investigational Site

Rennes, , France

Site Status

GSK Investigational Site

Saint-Herblain, , France

Site Status

GSK Investigational Site

Aachen, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Dresden, , Germany

Site Status

GSK Investigational Site

Essen, , Germany

Site Status

GSK Investigational Site

Fürth, , Germany

Site Status

GSK Investigational Site

Göttingen, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Heidelberg, , Germany

Site Status

GSK Investigational Site

Hildesheim, , Germany

Site Status

GSK Investigational Site

Mannheim, , Germany

Site Status

GSK Investigational Site

München, , Germany

Site Status

GSK Investigational Site

München, , Germany

Site Status

GSK Investigational Site

Debrecen, , Hungary

Site Status

GSK Investigational Site

Győr, , Hungary

Site Status

GSK Investigational Site

Dublin, , Ireland

Site Status

GSK Investigational Site

Dunmore RoadWaterford, , Ireland

Site Status

GSK Investigational Site

Galway, , Ireland

Site Status

GSK Investigational Site

Beersheba, , Israel

Site Status

GSK Investigational Site

Haifa, , Israel

Site Status

GSK Investigational Site

Haifa, , Israel

Site Status

GSK Investigational Site

Holon, , Israel

Site Status

GSK Investigational Site

Petah Tikva, , Israel

Site Status

GSK Investigational Site

Ramat Gan, , Israel

Site Status

GSK Investigational Site

Tel Aviv, , Israel

Site Status

GSK Investigational Site

Candiolo, , Italy

Site Status

GSK Investigational Site

Lecce, , Italy

Site Status

GSK Investigational Site

Milan, , Italy

Site Status

GSK Investigational Site

Milan, , Italy

Site Status

GSK Investigational Site

Mirano VE, , Italy

Site Status

GSK Investigational Site

Modena, , Italy

Site Status

GSK Investigational Site

Napoli, , Italy

Site Status

GSK Investigational Site

Oslo, , Norway

Site Status

GSK Investigational Site

Lublin, , Poland

Site Status

GSK Investigational Site

Olsztyn, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Arkhangelsk, , Russia

Site Status

GSK Investigational Site

Chelyabinsk, , Russia

Site Status

GSK Investigational Site

Irkutsk, , Russia

Site Status

GSK Investigational Site

Ivanovo, , Russia

Site Status

GSK Investigational Site

Kazan', , Russia

Site Status

GSK Investigational Site

Krasnoyarsk, , Russia

Site Status

GSK Investigational Site

Orenburg, , Russia

Site Status

GSK Investigational Site

Pyatigorsk, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Samara, , Russia

Site Status

GSK Investigational Site

Badalona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Córdoba, , Spain

Site Status

GSK Investigational Site

Donostia / San Sebastian, , Spain

Site Status

GSK Investigational Site

Elche Alicante, , Spain

Site Status

GSK Investigational Site

Girona, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Seville, , Spain

Site Status

GSK Investigational Site

Seville, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

GSK Investigational Site

Zaragoza, , Spain

Site Status

GSK Investigational Site

Stockholm, , Sweden

Site Status

GSK Investigational Site

Uppsala, , Sweden

Site Status

GSK Investigational Site

Basel, , Switzerland

Site Status

GSK Investigational Site

Bern, , Switzerland

Site Status

GSK Investigational Site

Frauenfeld, , Switzerland

Site Status

GSK Investigational Site

Zurich, , Switzerland

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

GSK Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kherson, , Ukraine

Site Status

GSK Investigational Site

Kryvyi Rih, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Vinnytsia, , Ukraine

Site Status

GSK Investigational Site

Zaporizhzhia, , Ukraine

Site Status

GSK Investigational Site

Bath, , United Kingdom

Site Status

GSK Investigational Site

Blackburn, , United Kingdom

Site Status

GSK Investigational Site

Edinburgh, , United Kingdom

Site Status

GSK Investigational Site

Exeter, , United Kingdom

Site Status

GSK Investigational Site

Glasgow, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Portsmouth, , United Kingdom

Site Status

GSK Investigational Site

Sheffield, , United Kingdom

Site Status

GSK Investigational Site

Staffordshire, , United Kingdom

Site Status

GSK Investigational Site

Truro, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Canada Czechia Denmark Finland France Germany Hungary Ireland Israel Italy Norway Poland Russia Spain Sweden Switzerland Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 39284381 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39019698 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39013265 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38950925 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38833992 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38501262 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38325276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37263896 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36172173 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35550709 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31562799 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.