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AzTrials

Ovarian NeoplasmsPhase 3NCT02655016

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

A Phase 3 study testing Niraparib in people with Ovarian Neoplasms, run by Tesaro, Inc. at 116 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 response (CR) or partial response (PR). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
Niraparib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
733 participants
Where
116 sitesin 14 countries
Study dates
11 Jul 2016to 29 May 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

116 sites in 14 countries.

116 sites in 14 countries

United States47 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Baltimore, Maryland, 21215-5271

  • GSK Investigational Site

    Burlington, Massachusetts, 01805

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599-7570

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Covington, Louisiana, 70433

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Geneva, Illinois, 60555

  • GSK Investigational Site

    Grand Rapids, Michigan, 49503

  • GSK Investigational Site

    Harrison, New York, 10604

  • GSK Investigational Site

    Indianapolis, Indiana, 46237

  • GSK Investigational Site

    Indianapolis, Indiana, 46260

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jacksonville, Florida, 32224

  • GSK Investigational Site

    Kennewick, Washington, 99336

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Mineola, New York, 11501

  • GSK Investigational Site

    Minneapolis, Minnesota, 55433

  • GSK Investigational Site

    Neptune City, New Jersey, 07753

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    New Orleans, Louisiana, 70121

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Providence, Rhode Island, 02905

  • GSK Investigational Site

    Rochester, New York, 14620

  • GSK Investigational Site

    Rockville, Maryland, 20910

  • GSK Investigational Site

    Salt Lake City, Utah, 84112

  • GSK Investigational Site

    San Francisco, California, 94115

  • GSK Investigational Site

    San Francisco, California, 94118

  • GSK Investigational Site

    Santa Rosa, California, 95403

  • GSK Investigational Site

    Savannah, Georgia, 31404

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105

  • GSK Investigational Site

    Spokane, Washington, 99202

  • GSK Investigational Site

    Springfield, Missouri, 97477

  • GSK Investigational Site

    Tempe, Arizona, 85284

  • GSK Investigational Site

    The Woodlands, Texas, 77380

  • GSK Investigational Site

    Tucson, Arizona, 85710

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Tulsa, Oklahoma, 74146

  • GSK Investigational Site

    Tyler, Texas, 75701

  • GSK Investigational Site

    Willow Grove, Pennsylvania, 19090

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

Other trials in United States

Spain17 sites

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Barcelona, 8035

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Donostia / San Sebastian, 20014

  • GSK Investigational Site

    Elche Alicante, 03203

  • GSK Investigational Site

    Girona, 17007

  • GSK Investigational Site

    Madrid, 28033

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Valencia, 46009

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Germany9 sites

  • GSK Investigational Site

    Aachen, 52074

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Essen, 45136

  • GSK Investigational Site

    Fürth, 90766

  • GSK Investigational Site

    Göttingen, 37075

  • GSK Investigational Site

    Heidelberg, 69120

  • GSK Investigational Site

    Hildesheim, 31134

  • GSK Investigational Site

    Mannheim, 68167

  • GSK Investigational Site

    München, 81377

Other trials in Germany

Belgium8 sites

  • GSK Investigational Site

    Bonheiden, 2820

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Hasselt, 3500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Libramont, 6800

  • GSK Investigational Site

    Namur, 5000

Other trials in Belgium

United Kingdom8 sites

  • GSK Investigational Site

    Blackburn, BB2 3HH

  • GSK Investigational Site

    Edinburgh, G12 0YN

  • GSK Investigational Site

    Exeter, EX2 5DW

  • GSK Investigational Site

    Glasgow, G12 0YN

  • GSK Investigational Site

    London, W12 0HS

  • GSK Investigational Site

    Portsmouth, PO6 3LY

  • GSK Investigational Site

    Sheffield, S10 2SJ

  • GSK Investigational Site

    Truro, TR1 3LJ

Other trials in United Kingdom

Italy5 sites

  • GSK Investigational Site

    Lecce, 73100

  • GSK Investigational Site

    Milan, 20132

  • GSK Investigational Site

    Milan, 20133

  • GSK Investigational Site

    Modena, 41100

  • GSK Investigational Site

    Naples, 80131

Other trials in Italy

Denmark4 sites

  • GSK Investigational Site

    Aalborg, 9000

  • GSK Investigational Site

    Copenhagen, 2100

  • GSK Investigational Site

    Herlev, 2730

  • GSK Investigational Site

    Odense C, 5000

Other trials in Denmark

Finland4 sites

  • GSK Investigational Site

    Kuopio, 70210

  • GSK Investigational Site

    Oulu, 90029

  • GSK Investigational Site

    Tampere, 33521

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Switzerland4 sites

  • GSK Investigational Site

    Basel, 4031

  • GSK Investigational Site

    Bern, 3010

  • GSK Investigational Site

    Frauenfeld, 8501

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

Ireland3 sites

  • GSK Investigational Site

    Dublin, 8

  • GSK Investigational Site

    Dunmore RoadWaterford

  • GSK Investigational Site

    Galway, H91 YR71

Other trials in Ireland

Israel3 sites

  • GSK Investigational Site

    Haifa, 38100

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Sweden2 sites

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

France1 site

  • GSK Investigational Site

    Angers, 49000

Other trials in France

Norway1 site

  • GSK Investigational Site

    Oslo, 0310

Other trials in Norway

About this study

Official title: 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

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.

Being tested
Niraparib, Placebo
Keywords
Ovarian Cancer, Niraparib, GSK3985771, Poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP)Inhibitor, Homologous recombination deficiency (HRD), HRD positive, PRIMA, PRIMA Clinical Trial, PRIMA Study
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Niraparib will be administered.

  • PlaceboDrug

    Placebo will be administered.

Study groups in NCT02655016
Study groupRoleWhat they receive
Participants receiving NiraparibExperimentalNot described
Receives: Drug: Niraparib
Participants receiving PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.

    Measured: Up to 34 months

Secondary outcomes (10)

  1. Overall Survival

    Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis.

    Measured: Up to 34 months

  2. Time to First Subsequent Therapy (TFST)

    Time to first subsequent therapy was defined as the time from the date of randomization to the date of the first subsequent anti-cancer therapy or death, whichever occurs first. Median and 95% CI are presented.

    Measured: Up to 34 months

  3. Progression-Free Survival-2 (PFS2)

    PFS2 was defined as the time from the date of randomization to the date of progression on the next anti-cancer therapy following study treatment or death by any cause, whichever occurs first. Median and 95% CI are presented.

    Measured: Up to 34 months

  4. Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)

    FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from "not at all" (0) to "very much" (4). FOSI score was calculated as (sum of item scores)*8 divided by (number of items answered). The FOSI score ranged from 0 (severely symptomatic) to 32 (asymptomatic). A higher score indicated a better quality of life (QoL). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

    Measured: Baseline (Day 1, Pre-dose) and Up to Week 24

  5. Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score

    The EQ-5D-5L is a well-validated general preference-based, health-related QoL instrument. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

    Measured: Baseline (Day 1, Pre-dose) and Up to Week 24

  6. Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)

    EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Five functional scales had total 15 items (physical-5, role-2, cognitive-4, emotional-2, and social-2). Each functional scales score was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

    Measured: Baseline (Day 1, Pre-dose) and Up to Week 24

  7. Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30

    EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. A global health status/QoL scale had total 2 items. Each global health status/QoL scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 6*100). The global health status/QoL scales range in score from 0 to 100. Higher score represents a higher ("better") level of health status/QoL. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

    Measured: Baseline (Day 1, Pre-dose) and Up to Week 24

  8. Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30

    EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Symptom scale had total 7 items (fatigue-3, pain-2, nausea/vomiting-2). Each symptoms scales and 6 single additional symptoms items score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales and 6 single additional symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

    Measured: Baseline (Day 1, Pre-dose) and Up to Week 24

  9. Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)

    EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal [GI] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

    Measured: Baseline (Day 1, Pre-dose) and Up to 34 months

  10. Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28

    EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/GI symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Symptoms scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

    Measured: Baseline (Day 1, Pre-dose) and Up to 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2016 (estimated)
  2. Study start11 Jul 2016
  3. Primary completion17 May 2019
  4. Study completion29 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
733 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655016
Sponsor's protocol ID
213359
Other IDs
PR-30-5017-C, 2023-508010-42, 2023
Status last verified
Feb 2026
First submitted
8 Dec 2015
Last updated
10 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39284381

  • Shahin MS, Lorusso D, Backes FJ, Barretina-Ginesta MP, O'Malley DM, Forget F, Pothuri B, Hietanen S, McCormick CC, Abadie-Lacourtoisie S, O'Cearbhaill RE, Heitz F, Moore RG, Amit A, Willmott LJ, Perez MR, Burger RA, Redondo A, Chase DM, Romero I, Moore KN, Vergote I, Cloven N, Haslund CA, Graybill WS, Bergamini A, Berton D, Braicu EI, Lim JT, Golembesky AK, Shtessel L, Monk BJ, Gonzalez-Martin A. Updated patient-reported outcomes and the effect of disease progression on health-related quality of life in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer. Gynecol Oncol. 2026 Jul 1;211:79-88. doi: 10.1016/j.ygyno.2026.06.010. Online ahead of print.

    PubMed 42385609

  • 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.

    PubMed 39019698

  • 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.

    PubMed 39013265

  • 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.

    PubMed 38950925

  • 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.

    PubMed 38833992

  • 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.

    PubMed 38501262

  • 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.

    PubMed 38325276

  • 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.

    PubMed 37263896

  • 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.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Niraparib in people with Ovarian Neoplasms, run by Tesaro, Inc. at 116 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Spain, Germany, Belgium, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Up to 34 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655016, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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