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
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- STATUS
- Recruiting
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- sponsor
- TESARO
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 Identifier | TX148226 |
|---|---|
| Sponsor | TESARO |
| Last Modified on | 25 March 2021 |
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