A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Tesaro, Inc.
Study ID
NCT01847274
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).

Key Dates

Start date
Jun 21, 2013
Status verified
May 2023
Primary completion
Apr 22, 2016
Completion
Dec 26, 2021

Study Design

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

Arms

  • Active Comparator: Niraparib
    2:1 Ratio administered once daily continuously during a 28 day cycle.
  • Placebo Comparator: Placebo
    Administered once daily continuously over a 28 day cycle.

Primary Outcome Measure

Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) [ Time Frame: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days ]

Locations (35)

FacilityCityStateZIPSite coordinators
GSK Investigational SitePhoenixArizona85013-
GSK Investigational SiteTucsonArizona85704-
GSK Investigational SiteLos AngelesCalifornia90027-
GSK Investigational SiteLos AngelesCalifornia90048-
GSK Investigational SitePalo AltoCalifornia94304-
GSK Investigational SiteSan FranciscoCalifornia94109-
GSK Investigational SiteNew HavenConnecticut06510-
GSK Investigational SiteSarasotaFlorida34232-
GSK Investigational SiteTampaFlorida33612-
GSK Investigational SiteAtlantaGeorgia30342-
GSK Investigational SiteChicagoIllinois60611-
GSK Investigational SiteIndianapolisIndiana46202-
GSK Investigational SiteIndianapolisIndiana46260-
GSK Investigational SiteBostonMassachusetts02115-
GSK Investigational SiteBostonMassachusetts02215-
GSK Investigational SiteBurlingtonMassachusetts01805-
GSK Investigational SiteMinneapolisMinnesota55404-
GSK Investigational SiteMinneapolisMinnesota55455-
GSK Investigational SiteRochesterMinnesota55905-
GSK Investigational SiteMorristownNew Jersey07962-1956-
GSK Investigational SiteFarmingtonNew Mexico87401-
GSK Investigational SiteLake SuccessNew York11042-
GSK Investigational SiteNew YorkNew York10016-
GSK Investigational SiteNew YorkNew York10065-
GSK Investigational SiteDurhamNorth Carolina27710-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SiteVancouverOregon98684-
GSK Investigational SiteAbingtonPennsylvania19001-3788-
GSK Investigational SitePhiladelphiaPennsylvania19111-
GSK Investigational SiteProvidenceRhode Island02905-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteAustinTexas78731-
GSK Investigational SiteDallasTexas75390-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteThe WoodlandsTexas77380-

Find similar trials in Phoenix, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
GSK Investigational Site· Phoenix, AZGSK Investigational Site· Tucson, AZGSK Investigational Site· Los Angeles, CAGSK Investigational Site· Palo Alto, CAGSK Investigational Site· San Francisco, CAGSK Investigational Site· New Haven, CT

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