A 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

  • STATUS
    Recruiting
  • sponsor
    TESARO
Updated on 23 November 2020

Summary

A 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

Description

This research study will look at how effective niraparib (a PARP inhibitor) is compared to placebo (a pill with no medicine in it, like a sugar pill) in maintenance therapy for women who have ovarian, fallopian tube or peritoneal cancer, and have responded (complete or partial response) to front-line platinum-based (i.e. carboplatin, cisplatin)chemotherapy. In this study, 2 out of 3 people will get niraparib and 1 out of 3 people will get placebo. Participants must have completed a front-line platinum based chemotherapy regimen with a Complete Response or Partial Response as determined by their doctor.

Those with Stage III disease must have cancer that remains after surgery (if surgery was an option). Participants must have a normal or more than 90% decrease in their CA-125 after front-line platinum chemotherapy.

Details
Clinical Study IdentifierTX148226
SponsorTESARO
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Are you female?
Not a complete listing of criteria
Stage 3 or 4 advanced, high-grade predominantly serious or endometriod ovarian, fallopian tube or primary peritoneal cancer and have completed first-line platinum-based chemotherapy (i.e. carboplatin, cisplatin) with a clinical complete or partial response
All those with Stage IV are eligible after primary or interval debulkingThose with Stage III must have visible disease after primary surgery. Those with Stage III or IV that cannot be operated on are eligible
Must agree to have tumor HRD testing
Must be placed in the niraparib or placebo group within 12 weeks after the first day of the last cycle of chemotherapy
Must not have had more than 2 debulking surgeries
Must not have gotten bevacizumab (Avastin) with front-line platinum-based chemotherapy
Must not have been treated with a known PARP inhibitor
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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