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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ovarian Neoplasms
• Intervention / Treatment: Drug: Placebo; Drug: Niraparib

• Study Type: Interventional
• Enrollment (Actual): 733
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • GSK Investigational Site
  • Bruxelles, Belgium, 1200
    • GSK Investigational Site
  • Bruxelles, Belgium, 1000
    • GSK Investigational Site
  • Charleroi, Belgium, 6000
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Hasselt, Belgium, 3500
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • Libramont, Belgium, 6800
    • GSK Investigational Site
  • Namur, Belgium, 5000
    • GSK Investigational Site
  • Sint-Niklaas, Belgium, 9100
    • GSK Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • GSK Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • GSK Investigational Site
    • Surrey, British Columbia, Canada, V3V 1Z2
      • GSK Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • GSK Investigational Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • GSK Investigational Site
    • London, Ontario, Canada, N6A 4L6
      • GSK Investigational Site
    • Ottawa, Ontario, Canada, K1Y 4E9
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M4N 3M5
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 1X6
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H4A 3J1
      • GSK Investigational Site
    • Montréal, Quebec, Canada, H2X 0A9
      • GSK Investigational Site
• Czechia
  • Brno, Czechia, 602 00
    • GSK Investigational Site
  • Ostrava, Czechia, 708 52
    • GSK Investigational Site
  • Plzen-Lochotin, Czechia, 30460
    • GSK Investigational Site
  • Prague, Czechia, 128 51
    • GSK Investigational Site
  • Prague, Czechia, 10034
    • GSK Investigational Site
• Denmark
  • Aalborg, Denmark, 9000
    • GSK Investigational Site
  • Herlev, Denmark, 2730
    • GSK Investigational Site
  • Koebenhavn Oe, Denmark, 2100
    • GSK Investigational Site
  • Odense, Denmark, 5000
    • GSK Investigational Site
• Finland
  • Kuopio, Finland, 70210
    • GSK Investigational Site
  • Oulu, Finland, 90029
    • GSK Investigational Site
  • Tampere, Finland, 33521
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• France
  • Angers, France, 49000
    • GSK Investigational Site
  • Caen Cedex 05, France, 14076
    • GSK Investigational Site
  • Montpellier Cedex 5, France, 34298
    • GSK Investigational Site
  • Nice Cedex 2, France, 06189
    • GSK Investigational Site
  • Paris, France, 75020
    • GSK Investigational Site
  • Pierre-Benite cedex, France, 69495
    • GSK Investigational Site
  • Rennes Cedex, France, 35042
    • GSK Investigational Site
  • Saint-Herblain, France, 44805
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13353
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • GSK Investigational Site
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • GSK Investigational Site
  • Bayern
    • Fuerth, Bayern, Germany, 90766
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81377
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81737
      • GSK Investigational Site
  • Niedersachsen
    • Goettingen, Niedersachsen, Germany, 37075
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
      • GSK Investigational Site
• Hungary
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
  • Gyor, Hungary, 9024
    • GSK Investigational Site
• Ireland
  • Galway, Ireland, H91 YR71
    • GSK Investigational Site
  • Waterford, Ireland
    • GSK Investigational Site
• Israel
  • Beer Sheva, Israel, 84101
    • GSK Investigational Site
  • Haifa, Israel, 3109601
    • GSK Investigational Site
  • Haifa, Israel, 38100
    • GSK Investigational Site
  • Holon, Israel, 58100
    • GSK Investigational Site
  • Tel Aviv, Israel, 64239
    • GSK Investigational Site
  • Tel Hashomer, Israel, 52621
    • GSK Investigational Site
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • GSK Investigational Site
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41100
      • GSK Investigational Site
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20133
      • GSK Investigational Site
  • Piemonte
    • Candiolo (TO), Piemonte, Italy, 10060
      • GSK Investigational Site
  • Veneto
    • Mirano, Veneto, Italy, 30035
      • GSK Investigational Site
• Norway
  • Oslo, Norway, 0310
    • GSK Investigational Site
• Poland
  • Lodz, Poland, 93-513
    • GSK Investigational Site
  • Lublin, Poland, 20-090
    • GSK Investigational Site
  • Olsztyn, Poland, 10-561
    • GSK Investigational Site
  • Poznan, Poland, 60-569
    • GSK Investigational Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • GSK Investigational Site
  • Chelyabinsk, Russian Federation, 454048
    • GSK Investigational Site
  • Irkutsk, Russian Federation, 664035
    • GSK Investigational Site
  • Ivanovo, Russian Federation, 153040
    • GSK Investigational Site
  • Kazan, Russian Federation, 420029
    • GSK Investigational Site
  • Krasnoyarsk, Russian Federation, 660133
    • GSK Investigational Site
  • Orenburg, Russian Federation, 460021
    • GSK Investigational Site
  • Pyatigorsk, Russian Federation, 357502
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 197758
    • GSK Investigational Site
  • Samara, Russian Federation, 443011
    • GSK Investigational Site
  • St-Petersburg, Russian Federation, 194017
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 191104
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 197758
    • GSK Investigational Site
• Spain
  • Badalona, Spain, 08916
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08003
    • GSK Investigational Site
  • Barcelona, Spain, 8035
    • GSK Investigational Site
  • Cordoba, Spain, 14004
    • GSK Investigational Site
  • Elche, Spain, 03203
    • GSK Investigational Site
  • Girona, Spain, 17007
    • GSK Investigational Site
  • Hospitalet de Llobregat, Barcelona, Spain, 08907
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Madrid, Spain, 28033
    • GSK Investigational Site
  • San Sebastián, Spain, 20014
    • GSK Investigational Site
  • Sevilla, Spain, 41013
    • GSK Investigational Site
  • Sevilla, Spain, 41014
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
  • Valencia, Spain, 46009
    • GSK Investigational Site
  • Zaragoza, Spain, 50009
    • GSK Investigational Site
• Sweden
  • Stockholm, Sweden, SE-171 76
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
• Switzerland
  • Basel, Switzerland, 4031
    • GSK Investigational Site
  • Bern, Switzerland, 3010
    • GSK Investigational Site
  • Frauenfeld, Switzerland, 8501
    • GSK Investigational Site
  • Zurich, Switzerland, 8091
    • GSK Investigational Site
• Ukraine
  • Dnipro, Ukraine, 49100
    • GSK Investigational Site
  • Dnipropetrovsk, Ukraine, 49102
    • GSK Investigational Site
  • Ivano-Frankivsk, Ukraine, 76000
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61070
    • GSK Investigational Site
  • Kherson, Ukraine, 73000
    • GSK Investigational Site
  • Krivoy Rog, Ukraine, 50048
    • GSK Investigational Site
  • Kyiv, Ukraine, 03022
    • GSK Investigational Site
  • Vinnitsia, Ukraine, 21029
    • GSK Investigational Site
  • Zaporizhzhia, Ukraine, 69040
    • GSK Investigational Site
• United Kingdom
  • Blackburn, United Kingdom, BB2 3HH
    • GSK Investigational Site
  • Exeter, United Kingdom, EX2 5DW
    • GSK Investigational Site
  • Glasgow, United Kingdom, G12 0YN
    • GSK Investigational Site
  • London, United Kingdom, W12 0HS
    • GSK Investigational Site
  • Sheffield, United Kingdom, S10 2SJ
    • GSK Investigational Site
  • Truro, United Kingdom, TR1 3LJ
    • GSK Investigational Site
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • GSK Investigational Site
  • Somerset
    • Bath, Somerset, United Kingdom, BA1 3NG
      • GSK Investigational Site
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • GSK Investigational Site
• United States
  • Arizona
    • Mesa, Arizona, United States, 85284
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85710
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85724
      • GSK Investigational Site
  • California
    • Los Angeles, California, United States, 90095
      • GSK Investigational Site
    • San Francisco, California, United States, 94115
      • GSK Investigational Site
    • San Francisco, California, United States, 94118
      • GSK Investigational Site
    • Santa Rosa, California, United States, 95403
      • GSK Investigational Site
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • GSK Investigational Site
    • New Haven, Connecticut, United States, 06510
      • GSK Investigational Site
  • Florida
    • Hollywood, Florida, United States, 33323
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32224
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Augusta, Georgia, United States, 30912
      • GSK Investigational Site
    • Savannah, Georgia, United States, 31404
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • GSK Investigational Site
    • Hinsdale, Illinois, United States, 60521
      • GSK Investigational Site
    • Warrenville, Illinois, United States, 60555
      • GSK Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • GSK Investigational Site
    • Indianapolis, Indiana, United States, 46260
      • GSK Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • GSK Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • GSK Investigational Site
    • Covington, Louisiana, United States, 70433
      • GSK Investigational Site
    • New Orleans, Louisiana, United States, 70121
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21215-5271
      • GSK Investigational Site
    • Silver Spring, Maryland, United States, 20910
      • GSK Investigational Site
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • GSK Investigational Site
    • Springfield, Massachusetts, United States, 01199
      • GSK Investigational Site
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • GSK Investigational Site
  • Missouri
    • Springfield, Missouri, United States, 65807
      • GSK Investigational Site
  • New Jersey
    • Middletown, New Jersey, United States, 07748
      • GSK Investigational Site
    • Neptune, New Jersey, United States, 07753
      • GSK Investigational Site
    • Teaneck, New Jersey, United States, 07666
      • GSK Investigational Site
  • New York
    • Buffalo, New York, United States, 14263
      • GSK Investigational Site
    • Harrison, New York, United States, 10604
      • GSK Investigational Site
    • Mineola, New York, United States, 11501
      • GSK Investigational Site
    • New York, New York, United States, 10065
      • GSK Investigational Site
    • New York, New York, United States, 10016
      • GSK Investigational Site
    • Rochester, New York, United States, 14620
      • GSK Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7570
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44124
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44111
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43210
      • GSK Investigational Site
    • Mayfield Heights, Ohio, United States, 44124
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
    • Tulsa, Oklahoma, United States, 74146
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • GSK Investigational Site
    • Springfield, Oregon, United States, 97477
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site
    • Willow Grove, Pennsylvania, United States, 19090
      • GSK Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • GSK Investigational Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78731
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • The Woodlands, Texas, United States, 77380
      • GSK Investigational Site
    • Tyler, Texas, United States, 75701
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • GSK Investigational Site
  • Washington
    • Kennewick, Washington, United States, 99336
      • GSK Investigational Site
    • Seattle, Washington, United States, 98104
      • GSK Investigational Site
    • Spokane, Washington, United States, 99202
      • GSK Investigational Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • GSK Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Participants receiving Placebo	Drug: Placebo; Placebo will be administered.
Experimental: Participants receiving Niraparib	Drug: Niraparib; Niraparib will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 34 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 34 months
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.	Up to 34 months
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.	Up to 34 months
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).	Baseline (Day 1, Pre-dose) and Up to Week 24
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).	Baseline (Day 1, Pre-dose) and Up to Week 24
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).	Baseline (Day 1, Pre-dose) and Up to Week 24
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).	Baseline (Day 1, Pre-dose) and Up to Week 24
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).	Baseline (Day 1, Pre-dose) and Up to Week 24
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).	Baseline (Day 1, Pre-dose) and Up to 34 months
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).	Baseline (Day 1, Pre-dose) and Up to 34 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE	An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.	Up to 34 months
Area Under the Curve (AUC) From 0 to the Last Quantifiable Concentration (AUC[0-last])	Blood samples were planned to be collected for assessment of AUC(0-last).	Up to 34 months
Peak Plasma Concentration (Cmax)	Blood samples were planned to be collected for assessment of Cmax.	Up to 34 months
Number of Participants With Positive HRD Test	Number of participants with positive HRD test was planned to be assessed.	Up to 34 months

Collaborators and Investigators

• Sponsor: Tesaro, Inc.
• Collaborators: Gynecologic Oncology Group; European Network of Gynaecological Oncological Trial Groups (ENGOT); Myriad Genetics, Inc.
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• Lorusso D, Guy H, Samyshkin Y, Hawkes C, Estenson K, Coleman RL. Feasibility Study of a Network Meta-Analysis and Unanchored Population-Adjusted Indirect Treatment Comparison of Niraparib, Olaparib, and Bevacizumab as Maintenance Therapies in Patients with Newly Diagnosed Advanced Ovarian Cancer. Cancers (Basel). 2022 Mar 2;14(5):1285. doi: 10.3390/cancers14051285.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2016
• Primary Completion (Actual): May 17, 2019
• Study Completion (Estimated): September 25, 2024

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimated): January 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Niraparib; Ovarian Cancer; GSK3985771; Poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP)Inhibitor; Homologous recombination deficiency (HRD); HRD positive; PRIMA; PRIMA Clinical Trial; PRIMA Study
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Niraparib
• Other Study ID Numbers: 213359; PR-30-5017-C (Other Identifier: Tesaro)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No