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NCT02257736 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 3 study of Prostatic Neoplasms, sponsored by Aragon Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
982
Enrollment target
20
Study locations

NCT02257736 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Aragon Pharmaceuticals. The registered enrollment target is 982 participants, above the 499-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (97% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT02257736, a Phase 3 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Aragon Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
982 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment of cancer using drugs\]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland \[gland that makes fluid that aids movement of sperm\]).

Conditions Studied

Prostatic Neoplasms

Interventions

  • DRUG Placebo
  • DRUG Apalutamide
  • DRUG Prednisone
  • DRUG Abiraterone acetate

Study Locations (20)

California

  • - La Mesa
  • - Los Angeles
  • - Modesto
  • - San Diego
  • - San Francisco
  • - Santa Barbara

Florida

  • - Jensen Beach
  • - Lakeland
  • - New Port Richey
  • - Ocala

Louisiana

  • - Marrero
  • - New Orleans
  • - Shreveport

Colorado

  • - Aurora
  • - Denver

Illinois

  • - Melrose
  • - Niles

Arizona

  • - Phoenix

Georgia

  • - Atlanta

Maine

  • - Auburn

Trial Details

FieldValue
Enrollment Target 982 participants
Start Date 2014-11-26
Est. Completion 2027-12-31
Phase Phase 3

Sponsor

Aragon Pharmaceuticals

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02257736

The ClinicalTrials.gov registry entry for NCT02257736 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 982 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 499-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (97% higher). The listed sponsor is Aragon Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT02257736 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Louisiana.

Frequently Asked Questions

What is clinical trial NCT02257736 about?

NCT02257736 is a clinical study titled "An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)". The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment o...

What is the current status of trial NCT02257736?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 982 participants. The study started on 2014-11-26. Estimated completion is 2027-12-31.

What conditions does trial NCT02257736 study?

This clinical trial studies the following conditions: Prostatic Neoplasms.

What interventions are being tested in trial NCT02257736?

The interventions under investigation include: Placebo (DRUG), Apalutamide (DRUG), Prednisone (DRUG), Abiraterone acetate (DRUG).

Who is sponsoring clinical trial NCT02257736?

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

Where is trial NCT02257736 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.