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JNJJanssen Research & Development, LLCRunning, no new patients

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Prostatic Neoplasms, Castration-Resistant

2Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

  • 4 insiders sold shares within a month

    Since Aug 17, 2026 · was worth 5, fading over time

    +2
Worry score2

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

No changes since Tremor started watching this trial.
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

See the official record on ClinicalTrials.gov (NCT03431350) ↗
  • Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/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