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

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified January 2026 by Tesaro, Inc.
Sponsor
Tesaro, Inc.
Information Provided by (Responsible Party)
Tesaro, Inc.
Clinicaltrials.gov Identifier
NCT02655016
Other Study ID Numbers:
213359
First Submitted
December 7, 2015
First Posted
January 12, 2016
Results First Posted
May 3, 2020
Last Update Posted
March 9, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Ovarian Neoplasms
Drug: NiraparibDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment733 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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 DateJuly 10, 2016
Actual Primary Completion DateMay 16, 2019
Actual Study Completion Date6d 23h from now

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures
  1. Progression Free Survival
    Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.
Secondary Outcome Measures
  1. Overall Survival
    Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis.
  2. Time to First Subsequent Therapy (TFST)
    Time to first subsequent therapy was defined as the time from the date of randomization to the date of the first subsequent anti-cancer therapy or death, whichever occurs first. Median and 95% CI are presented.
  3. Progression-Free Survival-2 (PFS2)
    PFS2 was defined as the time from the date of randomization to the date of progression on the next anti-cancer therapy following study treatment or death by any cause, whichever occurs first. Median and 95% CI are presented.
  4. Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)
    FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from "not at all" (0) to "very much" (4). FOSI score was calculated as (sum of item scores)\*8 divided by (number of items answered). The FOSI score ranged from 0 (severely symptomatic) to 32 (asymptomatic). A higher score indicated a better quality of life (QoL). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
  5. Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score
    The EQ-5D-5L is a well-validated general preference-based, health-related QoL instrument. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
  6. Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
    EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Five functional scales had total 15 items (physical-5, role-2, cognitive-4, emotional-2, and social-2). Each functional scales score was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus \[average score minus 1\] divided by 3\*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
  7. Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30
    EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. A global health status/QoL scale had total 2 items. Each global health status/QoL scales score was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 6\*100). The global health status/QoL scales range in score from 0 to 100. Higher score represents a higher ("better") level of health status/QoL. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
  8. Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30
    EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Symptom scale had total 7 items (fatigue-3, pain-2, nausea/vomiting-2). Each symptoms scales and 6 single additional symptoms items score was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 3\*100). All of the symptoms scales and 6 single additional symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
  9. Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)
    EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal \[GI\] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus \[average score minus 1\] divided by 3\*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 3\*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).
  10. Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28
    EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/GI symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Symptoms scales score was calculated by averaging scores of all scale items and transforming average scores linearly (\[average score minus 1\] divided by 3\*100). All of the symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
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
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.

Contacts and Locations

Sponsors and CollaboratorsTesaro, Inc.
Locations
GSK Investigational Site | Tempe Arizona, United States, 85284GSK Investigational Site | Tucson Arizona, United States, 85710GSK Investigational Site | Tucson Arizona, United States, 85724GSK Investigational Site | San Francisco California, United States, 94115GSK Investigational Site | San Francisco California, United States, 94118GSK Investigational Site | Santa Rosa California, United States, 95403GSK Investigational Site | New Haven Connecticut, United States, 06510GSK Investigational Site | Jacksonville Florida, United States, 32224GSK Investigational Site | Miami Florida, United States, 33136GSK Investigational Site | Atlanta Georgia, United States, 30342GSK Investigational Site | Savannah Georgia, United States, 31404GSK Investigational Site | Geneva Illinois, United States, 60555GSK Investigational Site | Indianapolis Indiana, United States, 46237GSK Investigational Site | Indianapolis Indiana, United States, 46260GSK Investigational Site | Iowa City Iowa, United States, 52242GSK Investigational Site | Covington Louisiana, United States, 70433GSK Investigational Site | New Orleans Louisiana, United States, 70121GSK Investigational Site | Baltimore Maryland, United States, 21215-5271GSK Investigational Site | Rockville Maryland, United States, 20910GSK Investigational Site | Burlington Massachusetts, United States, 01805GSK Investigational Site | Grand Rapids Michigan, United States, 49503GSK Investigational Site | Minneapolis Minnesota, United States, 55433GSK Investigational Site | Springfield Missouri, United States, 97477GSK Investigational Site | Neptune City New Jersey, United States, 07753GSK Investigational Site | Harrison New York, United States, 10604GSK Investigational Site | Mineola New York, United States, 11501GSK Investigational Site | New York New York, United States, 10016GSK Investigational Site | Rochester New York, United States, 14620GSK Investigational Site | Chapel Hill North Carolina, United States, 27599-7570GSK Investigational Site | Wilmington North Carolina, United States, 28401GSK Investigational Site | Columbus Ohio, United States, 43210GSK Investigational Site | Oklahoma City Oklahoma, United States, 73104GSK Investigational Site | Tulsa Oklahoma, United States, 74146GSK Investigational Site | Portland Oregon, United States, 97210GSK Investigational Site | Philadelphia Pennsylvania, United States, 19104GSK Investigational Site | Willow Grove Pennsylvania, United States, 19090GSK Investigational Site | Providence Rhode Island, United States, 02905GSK Investigational Site | Charleston South Carolina, United States, 29425GSK Investigational Site | Sioux Falls South Dakota, United States, 57105GSK Investigational Site | Fort Worth Texas, United States, 76104GSK Investigational Site | The Woodlands Texas, United States, 77380GSK Investigational Site | Tyler Texas, United States, 75701GSK Investigational Site | Salt Lake City Utah, United States, 84112GSK Investigational Site | Kennewick Washington, United States, 99336GSK Investigational Site | Seattle Washington, United States, 98104GSK Investigational Site | Spokane Washington, United States, 99202GSK Investigational Site | Milwaukee Wisconsin, United States, 53226GSK Investigational Site | Bonheiden , Belgium, 2820GSK Investigational Site | Brussels , Belgium, 1000GSK Investigational Site | Brussels , Belgium, 1200GSK Investigational Site | Ghent , Belgium, 9000GSK Investigational Site | Hasselt , Belgium, 3500GSK Investigational Site | Leuven , Belgium, 3000GSK Investigational Site | Libramont , Belgium, 6800GSK Investigational Site | Namur , Belgium, 5000GSK Investigational Site | Aalborg , Denmark, 9000GSK Investigational Site | Copenhagen , Denmark, 2100GSK Investigational Site | Herlev , Denmark, 2730GSK Investigational Site | Odense C , Denmark, 5000GSK Investigational Site | Kuopio , Finland, 70210GSK Investigational Site | Oulu , Finland, 90029GSK Investigational Site | Tampere , Finland, 33521GSK Investigational Site | Turku , Finland, 20520GSK Investigational Site | Angers , France, 49000GSK Investigational Site | Aachen , Germany, 52074GSK Investigational Site | Berlin , Germany, 13353GSK Investigational Site | Essen , Germany, 45136GSK Investigational Site | Fürth , Germany, 90766GSK Investigational Site | Göttingen , Germany, 37075GSK Investigational Site | Heidelberg , Germany, 69120GSK Investigational Site | Hildesheim , Germany, 31134GSK Investigational Site | Mannheim , Germany, 68167GSK Investigational Site | München , Germany, 81377GSK Investigational Site | Dublin , Ireland, 8GSK Investigational Site | Dunmore RoadWaterford , Ireland, GSK Investigational Site | Galway , Ireland, H91 YR71GSK Investigational Site | Haifa , Israel, 38100GSK Investigational Site | Ramat Gan , Israel, 52621GSK Investigational Site | Tel Aviv , Israel, 64239GSK Investigational Site | Lecce , Italy, 73100GSK Investigational Site | Milan , Italy, 20132GSK Investigational Site | Milan , Italy, 20133GSK Investigational Site | Modena , Italy, 41100GSK Investigational Site | Naples , Italy, 80131GSK Investigational Site | Oslo , Norway, 0310GSK Investigational Site | Badalona , Spain, 08916GSK Investigational Site | Barcelona , Spain, 08003GSK Investigational Site | Barcelona , Spain, 08036GSK Investigational Site | Barcelona , Spain, 08907GSK Investigational Site | Barcelona , Spain, 8035GSK Investigational Site | Córdoba , Spain, 14004GSK Investigational Site | Donostia / San Sebastian , Spain, 20014GSK Investigational Site | Elche Alicante , Spain, 03203GSK Investigational Site | Girona , Spain, 17007GSK Investigational Site | Madrid , Spain, 28033GSK Investigational Site | Madrid , Spain, 28041GSK Investigational Site | Madrid , Spain, 28046GSK Investigational Site | Seville , Spain, 41013GSK Investigational Site | Seville , Spain, 41014GSK Investigational Site | Valencia , Spain, 46009GSK Investigational Site | Valencia , Spain, 46010GSK Investigational Site | Zaragoza , Spain, 50009GSK Investigational Site | Stockholm , Sweden, SE-171 76GSK Investigational Site | Uppsala , Sweden, SE-751 85GSK Investigational Site | Basel , Switzerland, 4031GSK Investigational Site | Bern , Switzerland, 3010GSK Investigational Site | Frauenfeld , Switzerland, 8501GSK Investigational Site | Zurich , Switzerland, 8091GSK Investigational Site | Blackburn , United Kingdom, BB2 3HHGSK Investigational Site | Edinburgh , United Kingdom, G12 0YNGSK Investigational Site | Exeter , United Kingdom, EX2 5DWGSK Investigational Site | Glasgow , United Kingdom, G12 0YNGSK Investigational Site | London , United Kingdom, W12 0HSGSK Investigational Site | Portsmouth , United Kingdom, PO6 3LYGSK Investigational Site | Sheffield , United Kingdom, S10 2SJGSK Investigational Site | Truro , United Kingdom, TR1 3LJ
Investigators
Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full Text)
Documents provided by Tesaro, Inc.: Study Protocol  August 26, 2019Documents provided by Tesaro, Inc.: Statistical Analysis Plan  June 18, 2019