A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Tesaro, Inc.
Study ID
NCT02354586
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Key Dates

Start date
Mar 23, 2015
Status verified
Jul 2022
Primary completion
Feb 28, 2018
Completion
Aug 23, 2021

Study Design

Enrollment
463 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 3 years ]

Locations (48)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteChandlerArizona85224-
GSK Investigational SitePhoenixArizona85016-
GSK Investigational SiteTucsonArizona85710-
GSK Investigational SiteBurbankCalifornia91505-
GSK Investigational SiteDuarteCalifornia91010-
GSK Investigational SiteLos AngelesCalifornia90027-
GSK Investigational SiteLos AngelesCalifornia90048-
GSK Investigational SiteSan FranciscoCalifornia94118-
GSK Investigational SiteSanta BarbaraCalifornia93105-
GSK Investigational SiteStanfordCalifornia94305-5317-
GSK Investigational SiteNew HavenConnecticut06510-
GSK Investigational SiteTampaFlorida33612-
GSK Investigational SiteWest Palm BeachFlorida33401-
GSK Investigational SiteAtlantaGeorgia30342-
GSK Investigational SiteChicagoIllinois60611-
GSK Investigational SiteChicagoIllinois60637-
GSK Investigational SiteIndianapolisIndiana46260-
GSK Investigational SiteIndianapolisIndiana54244-
GSK Investigational SiteCovingtonLouisiana70433-
GSK Investigational SiteNew OrleansLouisiana70121-
GSK Investigational SiteBaltimoreMaryland21202-
GSK Investigational SiteBostonMassachusetts02115-
GSK Investigational SiteBostonMassachusetts02215-
GSK Investigational SiteBurlingtonMassachusetts01805-
GSK Investigational SiteAnn ArborMichigan48109-
GSK Investigational SiteMinneapolisMinnesota55455-
GSK Investigational SiteRochesterMinnesota55905-
GSK Investigational SiteSpringfieldMissouri65804-
GSK Investigational SiteHackensackNew Jersey07601-
GSK Investigational SiteMorristownNew Jersey07962-1956-
GSK Investigational SiteEast SetauketNew York11733-
GSK Investigational SiteJamaicaNew York11432-
GSK Investigational SiteLake SuccessNew York11042-
GSK Investigational SiteNew YorkNew York10065-
GSK Investigational SiteDurhamNorth Carolina27710-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SiteMedfordOregon97504-8342-
GSK Investigational SiteWynnewoodPennsylvania19096-
GSK Investigational SiteProvidenceRhode Island02905-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteAustinTexas78731-
GSK Investigational SiteDallasTexas75390-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteSan AntonioTexas78229-
GSK Investigational SiteThe WoodlandsTexas77380-
GSK Investigational SiteTylerTexas75702-
GSK Investigational SiteSpokaneWashington99202-
GSK Investigational SiteTacomaWashington98405-

Find similar trials in Chandler, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
GSK Investigational Site· Chandler, AZGSK Investigational Site· Phoenix, AZGSK Investigational Site· Tucson, AZGSK Investigational Site· Burbank, CAGSK Investigational Site· Duarte, CAGSK Investigational Site· Los Angeles, CA

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