22
Participants
Start Date
December 30, 2019
Primary Completion Date
January 1, 2025
Study Completion Date
January 1, 2025
Niraparib
Study treatment will be administered orally Q day continuously. Up to three capsules of 100mg strength will be taken at each dose administration. Initiation dose will be defined per current FDA guidelines for Niraparib treatment in ovarian cancer. Dose interruption (no longer than 28 days) will be allowed. Dose reduction will be allowed based on treatment side effects. Dose reductions to 2 capsules daily (200mg) and subsequently to 1 capsule daily (100mg) will be allowed. No further dose reductions will be allowed. The timing of efficacy or safety evaluations should not be affected by dose interruptions or reductions.
Cancer Institute at Lenox Hill, New York
RJ Zuckerberg Cancer Hospital, New Hyde Park
Imbert Cancer Center Northwell Health, Bay Shore
Greenlawn Cancer Institute, Northwell Health, Greenlawn
Rutgers Cancer Institute of New Jersey, New Brunswick
Rutgers NJ School of Medicine, Newark
Lead Sponsor
Tesaro, Inc.
INDUSTRY
Northwell Health
OTHER