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Trial record 1 of 1 for:    30-5017
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A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655016
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Results First Posted : June 11, 2020
Last Update Posted : August 14, 2020
Sponsor:
Collaborators:
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Tesaro, Inc.

Brief Summary:
This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in patients with Stage III or IV ovarian cancer. Patients must have completed front-line platinum based regimen with a physician-assessed response of Complete Response (CR) or Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess the efficacy of niraparib as maintenance treatment, as measured by PFS.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Ovarian Cancer Drug: Niraparib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 733 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2016
Actual Primary Completion Date : May 17, 2019
Estimated Study Completion Date : March 29, 2024


Arm Intervention/treatment
Experimental: Niraparib
Administered once daily continuously during a 28 day cycle.
Drug: Niraparib
Niraparib vs Placebo 2:1 ratio

Placebo Comparator: Placebo
Administered once daily continuously over a 28 day cycle
Drug: Placebo



Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Up to 34 months ]
    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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 34 months ]
    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.

  2. Time to First Subsequent Therapy (TFST) [ Time Frame: Up to 34 months ]
    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.

  3. Progression-Free Survival-2 (PFS2) [ Time Frame: Up to 34 months ]
    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.

  4. Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) [ Time Frame: Baseline (Day 1, Pre-dose) and Up to Week 24 ]
    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).

  5. Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score [ Time Frame: Baseline (Day 1, Pre-dose) and Up to Week 24 ]
    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).

  6. Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) [ Time Frame: Baseline (Day 1, Pre-dose) and Up to Week 24 ]
    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).

  7. Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30 [ Time Frame: Baseline (Day 1, Pre-dose) and Up to Week 24 ]
    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).

  8. Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 [ Time Frame: Baseline (Day 1, Pre-dose) and Up to Week 24 ]
    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).

  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) [ Time Frame: Baseline (Day 1, Pre-dose) and Up to 34 months ]
    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).

  10. Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28 [ Time Frame: Baseline (Day 1, Pre-dose) and Up to 34 months ]
    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).


Other Outcome Measures:
  1. Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE [ Time Frame: Up to 34 months ]
    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.

  2. Area Under the Curve (AUC) From 0 to the Last Quantifiable Concentration (AUC[0-last]) [ Time Frame: Up to 34 months ]
    Blood samples were planned to be collected for assessment of AUC(0-last).

  3. Peak Plasma Concentration (Cmax) [ Time Frame: Up to 34 months ]
    Blood samples were planned to be collected for assessment of Cmax.

  4. Number of Participants With Positive HRD Test [ Time Frame: Up to 34 months ]
    Number of participants with positive HRD test was planned to be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Patient must have histologically confirmed, advanced (FIGO Stage III or IV) high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have completed first line platinum based chemotherapy (neoadjuvant or adjuvant)
  • Patient must have clinical complete response or partial response following completion of chemotherapy course.
  • All Stage IV patients are eligible, irrespective of residual disease, after primary or interval debulking. Stage III patients are required to have visible residual disease after primary surgery. Patients with inoperable Stage III and IV disease are eligible
  • Patient must agree to undergo central tumor HRD testing
  • Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
  • Patient must be randomized within 12 weeks of the first day of the last cycle of chemotherapy

Main Exclusion Criteria:

  • Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
  • Patient has undergone more than 2 debulking surgeries
  • Patient is to receive bevacizumab as maintenance treatment
  • Patient is pregnant, breastfeeding, or expecting to conceive children, while receiving study treatment and for 180 days after the last dose of study treatment
  • Patient has had prior treatment with a known PARP inhibitor
  • Patient has been diagnosed and/or treated for any invasive cancer (other than study disease) less than 5 years prior to study enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655016


Locations
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United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85284
GSK Investigational Site
Tucson, Arizona, United States, 85710
GSK Investigational Site
Tucson, Arizona, United States, 85724
United States, California
GSK Investigational Site
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
United States, Connecticut
GSK Investigational Site
Hartford, Connecticut, United States, 06102
GSK Investigational Site
New Haven, Connecticut, United States, 06510
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32224
GSK Investigational Site
Miami, Florida, United States, 33136
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Augusta, Georgia, United States, 30912
GSK Investigational Site
Savannah, Georgia, United States, 31404
United States, Illinois
GSK Investigational Site
Geneva, Illinois, United States, 60134
GSK Investigational Site
Hinsdale, Illinois, United States, 60521
GSK Investigational Site
Warrenville, Illinois, United States, 60555
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242-1009
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70817
GSK Investigational Site
Covington, Louisiana, United States, 70433
GSK Investigational Site
New Orleans, Louisiana, United States, 70121
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21215-5271
GSK Investigational Site
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
GSK Investigational Site
Burlington, Massachusetts, United States, 01805
GSK Investigational Site
Springfield, Massachusetts, United States, 01199
United States, Michigan
GSK Investigational Site
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, New Jersey
GSK Investigational Site
Middletown, New Jersey, United States, 07748
GSK Investigational Site
Neptune, New Jersey, United States, 07753
GSK Investigational Site
Teaneck, New Jersey, United States, 07666
United States, New York
GSK Investigational Site
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, 10016
GSK Investigational Site
New York, New York, United States, 10065
GSK Investigational Site
Rochester, New York, United States, 14620
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7570
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44111
GSK Investigational Site
Cleveland, Ohio, United States, 44124
GSK Investigational Site
Columbus, Ohio, United States, 43210
GSK Investigational Site
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
GSK Investigational Site
Tulsa, Oklahoma, United States, 74146
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
GSK Investigational Site
Springfield, Oregon, United States, 97477
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02905
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29425
United States, South Dakota
GSK Investigational Site
Sioux Falls, South Dakota, United States, 57105
United States, Texas
GSK Investigational Site
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
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84112
United States, Washington
GSK Investigational Site
Kennewick, Washington, United States, 99336
GSK Investigational Site
Seattle, Washington, United States, 98104
GSK Investigational Site
Spokane, Washington, United States, 99202
United States, West Virginia
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Belgium
GSK Investigational Site
Bonheiden, Belgium, 2820
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Bruxelles, Belgium, 1200
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
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 5L3
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 1Z2
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
GSK Investigational Site
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
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3A 1A1
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
GSK Investigational Site
Montréal, Quebec, Canada, H2X 0A9
Czechia
GSK Investigational Site
Brno, Czechia, 602 00
GSK Investigational Site
Plzen-Lochotin, Czechia, 30460
GSK Investigational Site
Prague, Czechia, 10034
GSK Investigational Site
Prague, Czechia, 128 51
Denmark
GSK Investigational Site
Aalborg, Denmark, 9000
GSK Investigational Site
Copenhagen, Denmark, DK-2100
GSK Investigational Site
Herlev, Denmark, 2730
GSK Investigational Site
Odense, Denmark, 5000
Finland
GSK Investigational Site
Kuopio, Finland, 70210
GSK Investigational Site
Oulu, Finland, 90029
GSK Investigational Site
Tampere, Finland, 33521
GSK Investigational Site
Turku, Finland, 20520
France
GSK Investigational Site
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 Cedex 15, France, 75908
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
Germany
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76135
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Schwaebisch Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Fuerth, Bayern, Germany, 90766
GSK Investigational Site
Muenchen, Bayern, Germany, 81377
GSK Investigational Site
Muenchen, Bayern, Germany, 81737
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45136
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 20246
Hungary
GSK Investigational Site
Debrecen, Hungary, 4032
GSK Investigational Site
Gyor, Hungary, 9024
Ireland
GSK Investigational Site
Dublin, Ireland, 8
GSK Investigational Site
Galway, Ireland, H91 YR71
GSK Investigational Site
Waterford, Ireland
GSK Investigational Site
Wilton, Cork, Ireland
Israel
GSK Investigational Site
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
Petach Tikva, Israel, 49100
GSK Investigational Site
Tel Aviv, Israel, 64239
GSK Investigational Site
Tel Hashomer, Israel, 52621
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Meldola (FC), Emilia-Romagna, Italy, 47014
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41100
GSK Investigational Site
Milano, Lombardia, Italy, 20132
GSK Investigational Site
Milano, Lombardia, Italy, 20133
GSK Investigational Site
Milano, Lombardia, Italy, 20141
GSK Investigational Site
Candiolo (TO), Piemonte, Italy, 10060
GSK Investigational Site
Lecce, Puglia, Italy, 73100
GSK Investigational Site
Mirano, Veneto, Italy, 30035
Norway
GSK Investigational Site
Bergen, Norway, 5021
GSK Investigational Site
Oslo, Norway, 0310
Poland
GSK Investigational Site
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
Russian Federation
GSK Investigational Site
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
St-Petersburg, Russian Federation, 194017
GSK Investigational Site
St. Petersburg, Russian Federation, 191104
GSK Investigational Site
St. Petersburg, Russian Federation, 197758
Spain
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08036
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, 28033
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
Sevilla, Spain, 41013
GSK Investigational Site
Sevilla, Spain, 41014
GSK Investigational Site
Valencia, Spain, 46009
GSK Investigational Site
Valencia, Spain, 46010
GSK Investigational Site
Zaragoza, Spain, 50009
Sweden
GSK Investigational Site
Stockholm, Sweden, SE-171 76
GSK Investigational Site
Uppsala, Sweden, SE-751 85
Switzerland
GSK Investigational Site
Basel, Switzerland, 4031
GSK Investigational Site
Bern, Switzerland, 3010
GSK Investigational Site
Frauenfeld, Switzerland, 8501
GSK Investigational Site
Zurich, Switzerland, 8091
Ukraine
GSK Investigational Site
Dnipropetrovsk, Ukraine, 49102
GSK Investigational Site
Dnipro, Ukraine, 49100
GSK Investigational Site
Ivano-Frankivsk, Ukraine, 76000
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
United Kingdom
GSK Investigational Site
Portsmouth, Hampshire, United Kingdom, PO6 3LY
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
GSK Investigational Site
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
GSK Investigational Site
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
Sponsors and Collaborators
Tesaro, Inc.
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetics, Inc.
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by Tesaro, Inc.:
Study Protocol  [PDF] August 27, 2019
Statistical Analysis Plan  [PDF] June 19, 2019

Publications:
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Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02655016    
Other Study ID Numbers: 213359
PR-30-5017-C ( Other Identifier: Tesaro )
First Posted: January 13, 2016    Key Record Dates
Results First Posted: June 11, 2020
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tesaro, Inc.:
Ovarian Cancer
PARP Inhibitor
HRD
HRD positive
PRIMA
PRIMA Clinical Trial
PRIMA Study
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents