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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Tesaro, Inc.
Study ID
NCT02655016
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib will be administered.
  • Placebo — DRUG
    Placebo will be administered.

Study Details

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.

Key Dates

Start date
Jul 11, 2016
Status verified
Feb 2026
Primary completion
May 17, 2019
Completion
May 29, 2026

Study Design

Enrollment
733 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving Niraparib
  • Placebo Comparator: Participants receiving Placebo

Primary Outcome Measure

Progression Free Survival [ Time Frame: Up to 34 months ]

Locations (47)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteTempeArizona85284-
GSK Investigational SiteTucsonArizona85710-
GSK Investigational SiteTucsonArizona85724-
GSK Investigational SiteSan FranciscoCalifornia94115-
GSK Investigational SiteSan FranciscoCalifornia94118-
GSK Investigational SiteSanta RosaCalifornia95403-
GSK Investigational SiteNew HavenConnecticut06510-
GSK Investigational SiteJacksonvilleFlorida32224-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteAtlantaGeorgia30342-
GSK Investigational SiteSavannahGeorgia31404-
GSK Investigational SiteGenevaIllinois60555-
GSK Investigational SiteIndianapolisIndiana46237-
GSK Investigational SiteIndianapolisIndiana46260-
GSK Investigational SiteIowa CityIowa52242-
GSK Investigational SiteCovingtonLouisiana70433-
GSK Investigational SiteNew OrleansLouisiana70121-
GSK Investigational SiteBaltimoreMaryland21215-5271-
GSK Investigational SiteRockvilleMaryland20910-
GSK Investigational SiteBurlingtonMassachusetts01805-
GSK Investigational SiteGrand RapidsMichigan49503-
GSK Investigational SiteMinneapolisMinnesota55433-
GSK Investigational SiteSpringfieldMissouri97477-
GSK Investigational SiteNeptune CityNew Jersey07753-
GSK Investigational SiteHarrisonNew York10604-
GSK Investigational SiteMineolaNew York11501-
GSK Investigational SiteNew YorkNew York10016-
GSK Investigational SiteRochesterNew York14620-
GSK Investigational SiteChapel HillNorth Carolina27599-7570-
GSK Investigational SiteWilmingtonNorth Carolina28401-
GSK Investigational SiteColumbusOhio43210-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SiteTulsaOklahoma74146-
GSK Investigational SitePortlandOregon97210-
GSK Investigational SitePhiladelphiaPennsylvania19104-
GSK Investigational SiteWillow GrovePennsylvania19090-
GSK Investigational SiteProvidenceRhode Island02905-
GSK Investigational SiteCharlestonSouth Carolina29425-
GSK Investigational SiteSioux FallsSouth Dakota57105-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteThe WoodlandsTexas77380-
GSK Investigational SiteTylerTexas75701-
GSK Investigational SiteSalt Lake CityUtah84112-
GSK Investigational SiteKennewickWashington99336-
GSK Investigational SiteSeattleWashington98104-
GSK Investigational SiteSpokaneWashington99202-
GSK Investigational SiteMilwaukeeWisconsin53226-

Find similar trials in Tempe, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
GSK Investigational Site· Tempe, AZGSK Investigational Site· Tucson, AZGSK Investigational Site· San Francisco, CAGSK Investigational Site· Santa Rosa, CAGSK Investigational Site· New Haven, CTGSK Investigational Site· Jacksonville, FL

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