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NCT02578797 · ClinicalTrials.gov registry record · Phase 1

A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study

A Phase 1 study, sponsored by Aragon Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target

NCT02578797: Completed Phase 1 study, sponsored by Aragon Pharmaceuticals.

NCT02578797 is a Phase 1 study that has completed, run by Aragon Pharmaceuticals. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02578797, a Phase 1 study, has completed, sponsored by Aragon Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether daily treatment with apalutamide affects the ventricular repolarization in participants with Castration-Resistant Prostate Cancer (CRPC)

Primary Outcome

Mean change from baseline in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.

Interventions

  • DRUG Apalutamide

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2015-12-18
Est. Completion 2022-10-13
Phase Phase 1
Aragon Pharmaceuticals

12 total trials

What the finished NCT02578797 record still lists

NCT02578797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 1 intervention - of which Apalutamide is the first listed.

NCT02578797 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02578797 about?

NCT02578797 is a clinical study titled "A JNJ-56021927 (ARN-509; Apalutamide) QT/QTc Study". The purpose of this study is to determine whether daily treatment with apalutamide affects the ventricular repolarization in participants with Castration-Resistant Prostate Cancer (CRPC)

What is the current status of trial NCT02578797?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2015-12-18. Estimated completion is 2022-10-13.

What interventions are being tested in trial NCT02578797?

The interventions under investigation include: Apalutamide (DRUG).

Who is sponsoring clinical trial NCT02578797?

This trial is sponsored by Aragon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02578797's enrollment target sits among peer trials

45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02578797, the US trial registry maintained by the National Library of Medicine. NCT02578797 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.