Clinical Trial

Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

Recruiting Phase 2
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Record status
This record was last updated November 22, 2023 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are: What is the incidence of hematologic and other adverse events? What is the incidence of dose interruption, dose reduction and discontinuation? What is the length of time of progression-free survival at 24 months?
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-18; most recent amendment 2023-11-21.
Status change: Not Yet Recruiting → Recruiting 2023-11-21
Trial Details
NCT Number NCT05961124
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: GlaxoSmithKline
Conditions Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer, High Grade Ovarian Serous Adenocarcinoma
Enrollment 40 participants
Start Date 2023-08-21
Primary Completion 2025-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2023-11-22