Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study ID
NCT02354131
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS) PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease. In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone. The question is: Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib.

Key Dates

Start date
Feb 15, 2015
Status verified
Aug 2022
Primary completion
Nov 15, 2018
Completion
Dec 15, 2021

Study Design

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

Arms

  • Experimental: Niraparib monotherapy
    Niraparib mono therapy until progression
  • Experimental: Niraparib-bevacizumab combination
    Niraparib-bevacizumab combination therapy until progression

Primary Outcome Measure

Progression free survival [ Time Frame: 30 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts--

Find similar trials in Boston, MA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Massachusetts General Hospital· Boston, MA

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