The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
765
Participants will receive niraparib 200 mg capsules or tablets once daily.
Participants will receive AA 1000 mg tablets once daily.
Participants will receive prednisone 10 mg tablets daily.
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; (2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (\>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan \>=2 new lesions indicate progression; scan does not show \>=2 new lesions means no progression. If Week 8 scan less than (\<) 2 new bone lesions compared to baseline, the initial scan \>=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan \>=6 weeks later.
Time frame: Up to 32 months
Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan \>=6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan \>=2 new lesions indicate progression; scan does not show \>=2 new lesions means no progression. If Week 8 scan \<2 new bone lesions compared to baseline, the initial scan \>=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan \>=6 weeks later.
Time frame: Up to 32 months
Cohort 1: Overall Survival (OS)
Time frame: Up to 97 months
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Participants will receive matching placebo once daily.
Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.
Urology Centers Of Alabama
Homewood, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Kaiser Permanente
Riverside, California, United States
San Bernardino Urological Associates
San Bernardino, California, United States
University of California San Francisco
San Francisco, California, United States
Sansum Clinic Pharm
Santa Barbara, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Colorado Clinical Research
Lakewood, Colorado, United States
...and 308 more locations
Cohort 1: Time to Symptomatic Progression
Time frame: Up to 97 months
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
Time frame: Up to 97 months
Observed Plasma Concentrations of Niraparib
Time frame: Up to 97 months
Observed Plasma Concentrations of Abiraterone
Time frame: Up to 97 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 96 months
Number of Participants With Treatment-Emergent Adverse Events by Severity
Time frame: Up to 96 months
Number of Participants With Abnormalities in Laboratory Values
Time frame: Up to 96 months