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

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

ClinicalTrials.gov processed this data on September 17, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)
Verified September 2024 by Tesaro, Inc., Gynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetics, Inc.

Sponsor

Tesaro, Inc.

Information Provided by (Responsible Party)

Tesaro, Inc.

Clinicaltrials.gov Identifier

NCT02655016
Other Study ID Numbers: 213359
First Submitted: December 8, 2015
First Posted: January 13, 2016
Results First Posted: June 11, 2020
Last Update Posted: October 2, 2024
Last Verified: September 2024
History of Changes

Disclaimer

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.

Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.

Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.

For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.

See also the Web Policies and Notices for the NIH web site.

Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Ovarian Neoplasms	Drug: Niraparib Drug: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	733 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
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
Study Start Date	July 11, 2016
Actual Primary Completion Date	May 17, 2019
Anticipated Study Completion Date	September 30, 2025

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Participants receiving Niraparib	Drug: Niraparib Niraparib will be administered.
Participants receiving Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Progression Free Survival [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

Overall Survival [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.
Time to First Subsequent Therapy (TFST) [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.
Progression-Free Survival-2 (PFS2) [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.
Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) [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).
Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score [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).
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) [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).
Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30 [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).
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 [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).
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) [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).
Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28 [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).

Eligibility Criteria

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

Contacts and Locations

Sponsors and Collaborators	Tesaro, Inc., Gynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetics, Inc.
	Gynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetics, Inc.
Locations	GSK Investigational Site \| Tempe, Arizona, United States, 85284 GSK Investigational Site \| Tucson, Arizona, United States, 85710 GSK Investigational Site \| Tucson, Arizona, United States, 85724 GSK Investigational Site \| Hollywood, California, United States, 33323 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 GSK Investigational Site \| Hartford, Connecticut, United States, 06102 GSK Investigational Site \| New Haven, Connecticut, United States, 06510 GSK Investigational Site \| Jacksonville, Florida, United States, 32224 GSK Investigational Site \| Miami, Florida, United States, 33136 GSK Investigational Site \| Atlanta, Georgia, United States, 30342 GSK Investigational Site \| Augusta, Georgia, United States, 30912 GSK Investigational Site \| Savannah, Georgia, United States, 31404 GSK Investigational Site \| Chicago, Illinois, United States, 60612 GSK Investigational Site \| Hinsdale, Illinois, United States, 60521 GSK Investigational Site \| Warrenville, Illinois, United States, 60555 GSK Investigational Site \| Indianapolis, Indiana, United States, 46237 GSK Investigational Site \| Indianapolis, Indiana, United States, 46260 GSK Investigational Site \| Iowa City, Iowa, United States, 52242-1009 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 GSK Investigational Site \| Baltimore, Maryland, United States, 21215-5271 GSK Investigational Site \| Rockville, Maryland, United States, 20910 GSK Investigational Site \| Burlington, Massachusetts, United States, 01805 GSK Investigational Site \| Springfield, Massachusetts, United States, 01199 GSK Investigational Site \| Grand Rapids, Michigan, United States, 49503 GSK Investigational Site \| Minneapolis, Minnesota, United States, 55404 GSK Investigational Site \| Springfield, Missouri, United States, 65807 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 GSK Investigational Site \| Buffalo, New York, United States, 14263 GSK Investigational Site \| Geneva, New York, United States, 60555 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 GSK Investigational Site \| Chapel Hill, North Carolina, United States, 27599-7570 GSK Investigational Site \| Wilmington, North Carolina, United States, 28401 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 Hts, Ohio, United States, 44124 GSK Investigational Site \| Oklahoma City, Oklahoma, United States, 73104 GSK Investigational Site \| Tulsa, Oklahoma, United States, 74146 GSK Investigational Site \| Portland, Oregon, United States, 97210 GSK Investigational Site \| Springfield, Oregon, United States, 97477 GSK Investigational Site \| Philadelphia, Pennsylvania, United States, 19104 GSK Investigational Site \| Willow Grove, Pennsylvania, United States, 19090 GSK Investigational Site \| Providence, Rhode Island, United States, 02905 GSK Investigational Site \| Charleston, South Carolina, United States, 29425 GSK Investigational Site \| Sioux Falls, South Dakota, United States, 57105 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 GSK Investigational Site \| Salt Lake City, Utah, United States, 84112 GSK Investigational Site \| Kennewick, Washington, United States, 99336 GSK Investigational Site \| Seattle, Washington, United States, 98104 GSK Investigational Site \| Spokane, Washington, United States, 99202 GSK Investigational Site \| Morgantown, West Virginia, United States, 26505 GSK Investigational Site \| Milwaukee, Wisconsin, United States, 53226 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 GSK Investigational Site \| Calgary, Alberta, Canada, T2N 4N2 GSK Investigational Site \| Surrey, British Columbia, Canada, V3V 1Z2 GSK Investigational Site \| Vancouver, British Columbia, Canada, V5Z 4E6 GSK Investigational Site \| Toronto, Ontario, Canada, M4N 3M5 GSK Investigational Site \| Greenfield Park, Quebec, Canada, J4V 2H1 GSK Investigational Site \| Montreal, Quebec, Canada, H2X 0A9 GSK Investigational Site \| Montreal, Quebec, Canada, H3T 1E2 GSK Investigational Site \| Montreal, Quebec, Canada, H4A 3J1 GSK Investigational Site \| Barrie, Canada, L4M 6M2 GSK Investigational Site \| Kelowna, Canada, V1Y 5L3 GSK Investigational Site \| London, Canada, N6A 4L6 GSK Investigational Site \| Ottawa, Canada, K1Y 4E9 GSK Investigational Site \| Toronto, Canada, M5G 1X6 GSK Investigational Site \| Brno, Czechia, 602 00 GSK Investigational Site \| Ostrava, Czechia, 708 52 GSK Investigational Site \| Plzen, Czechia, 30460 GSK Investigational Site \| Prague, Czechia, 10034 GSK Investigational Site \| Prague, Czechia, 128 51 GSK Investigational Site \| Aalborg, Denmark, 9000 GSK Investigational Site \| Herlev, Denmark, 2730 GSK Investigational Site \| Koebenhavn, Denmark, 2100 GSK Investigational Site \| Odense C, Denmark, 5000 GSK Investigational Site \| Kuopio, Finland, 70210 GSK Investigational Site \| Oulu, Finland, 90029 GSK Investigational Site \| Tampere, Finland, 33521 GSK Investigational Site \| Turku, Finland, 20520 GSK Investigational Site \| Angers cedex 9, France, 49000 GSK Investigational Site \| Caen Cedex 5, France, 14076 GSK Investigational Site \| Montpellier Cedex 5, France, 34298 GSK Investigational Site \| Nice, 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 cedex, France, 44805 GSK Investigational Site \| Berlin, Germany, 13353 GSK Investigational Site \| Essen, Germany, 45136 GSK Investigational Site \| Fuerth, Germany, 90766 GSK Investigational Site \| Goettingen, Germany, 37075 GSK Investigational Site \| Hamburg, Germany, 20246 GSK Investigational Site \| Heidelberg, Germany, 69120 GSK Investigational Site \| Ludwigshafen, Germany, 67063 GSK Investigational Site \| Mannheim, Germany, 68167 GSK Investigational Site \| Muenchen, Germany, 81377 GSK Investigational Site \| Munchen, Germany, 81737 GSK Investigational Site \| Debrecen, Hungary, 4032 GSK Investigational Site \| Gyor, Hungary, 9024 GSK Investigational Site \| Dunmore RoadWaterford, Ireland, GSK Investigational Site \| Galway, Ireland, H91 YR71 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 \| Tel Aviv, Israel, 64239 GSK Investigational Site \| Tel Hashomer, Israel, 52621 GSK Investigational Site \| Candiolo, Italy, 10060 GSK Investigational Site \| Milano, Italy, 20132 GSK Investigational Site \| Milano, Italy, 20133 GSK Investigational Site \| Mirano VE, Italy, 30035 GSK Investigational Site \| Modena, Italy, 41100 GSK Investigational Site \| Napoli, Italy, 80131 GSK Investigational Site \| Oslo, Norway, 0310 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 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 \| Samara, Russian Federation, 443011 GSK Investigational Site \| St Petersburg, Russian Federation, 191104 GSK Investigational Site \| St Petersburg, Russian Federation, 197758 GSK Investigational Site \| St-Petersburg, Russian Federation, 194017 GSK Investigational Site \| Badalona, Spain, 08916 GSK Investigational Site \| Barcelona, Spain, 08003 GSK Investigational Site \| Barcelona, Spain, 08036 GSK Investigational Site \| Barcelona, Spain, 08907 GSK Investigational Site \| Barcelona, Spain, 8035 GSK Investigational Site \| Cordoba, Spain, 14004 GSK Investigational Site \| Elche Alicante, Spain, 03203 GSK Investigational Site \| Gerona, Spain, 17007 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 SebastiAn, 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 GSK Investigational Site \| Stockholm, Sweden, SE-171 76 GSK Investigational Site \| Uppsala, Sweden, SE-751 85 GSK Investigational Site \| Basel, Switzerland, 4031 GSK Investigational Site \| Bern, Switzerland, 3010 GSK Investigational Site \| Frauenfeld, Switzerland, 8501 GSK Investigational Site \| Zuerich, Switzerland, 8091 GSK Investigational Site \| Dnipropetrovsk, 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 \| Vinnytsia, Ukraine, 21029 GSK Investigational Site \| Zaporizhzhia, Ukraine, 69040 GSK Investigational Site \| Bath, United Kingdom, BA1 3NG GSK Investigational Site \| Blackburn, United Kingdom, BB2 3HH GSK Investigational Site \| Edinburgh, United Kingdom, G12 0YN 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 \| Portsmouth, United Kingdom, PO6 3LY GSK Investigational Site \| Sheffield, United Kingdom, S10 2SJ GSK Investigational Site \| Staffordshire, United Kingdom, ST4 6QG GSK Investigational Site \| Truro, United Kingdom, TR1 3LJ
Investigators

Study Documents (Full Text)

Documents Provided by Tesaro, Inc.: Study Protocol August 27, 2019
Documents Provided by Tesaro, Inc.: Statistical Analysis Plan June 19, 2019

More Information

Publications

González-Martín A, Pothuri B, Vergote I, Christensen RD, Graybill W, Mirza M, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore R, Vulsteke C, O'Cearbhaill R, Lund B, Backes F, Barretina-Ginesta P, Haggerty A, Rubio-Pérez MJ, Shahin M, Mangili G, Bradley W, Bruchim I, Myriad or TESARO, Malinowska I, Li Y, Gupta D, Monk B. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019;Dec 19(381(25)):2391-2402
Lorusso D, Guy H, Samyshkin Y, Hawkes C, Estenson K, Coleman R.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;14(5):1285 DOI: 10.3390/cancers14051285 PMID: 35267593
Barretina-Ginesta MP, Monk B, Han S , Pothuri B, Auranen A, Chase D, 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, González-Martín 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;14 DOI: https://doi.org/10.1177/17588359221126149
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.
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.

Additional Relevant MeSH Terms

Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type