A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
- +2
4 insiders sold shares within a month
Since Aug 17, 2026 · was worth 5, fading over time
Score over time
- Stage
- Phase 2
- Patients
- 136 (final count)
- Started
- Mar 2, 2018
- Main results expected
- Aug 31, 2021
- Fully finished
- Dec 31, 2026
- Results posted
- Nov 18, 2023
What counts as success
The trial's main goal(s), called the “primary outcome.”
Combination 1: Part 1: Number of Participants With Specified Toxicity
Measured over: Cycle 1 (28 days)
Combination 1: Part 2: Objective Response Rate (ORR)
Measured over: Up to 37 months
Combination 2: Composite Response Rate (RR)
Measured over: Up to 31 months
Combination 1: Part 2: Number of Participants With Adverse Events (AEs)
Measured over: Up to 37 months
Combination 2: Number of Participants With Adverse Events (AEs)
Measured over: Up to 31 months
Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
Measured over: Up to 37 months
Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
Measured over: Up to 31 months
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose
Measured over: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose
Measured over: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose
Measured over: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Changes Tremor has spotted
Show details (technical version)
Score inputs
- insider_selling_cluster: base 5, now 2, since 2026-08-17, fades (half-life)
Raw record changes
- none yet
Trial ID NCT03431350 · record last updated 2026-09-28 · checked 2026-11-09 15:42 UTC