Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
Full description
Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts (550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib (AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, or until treatment is stopped for another reason.
All patients will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib + physicians choice NHA.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
determine cohort eligibility
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,800 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal