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NCT04464226 · ClinicalTrials.gov registry record · Phase 3

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

A Phase 3 study of Cancer, sponsored by Bayer.

Recruiting
Registry status
Phase 3
Development phase
402
Enrollment target
20
Study locations

NCT04464226 is a Phase 3 study of Cancer that is actively recruiting participants, run by Bayer. The registered enrollment target is 402 participants, below the 3,490-participant average among 615 other Cancer trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT04464226, a Phase 3 study of Cancer, is actively recruiting participants, sponsored by Bayer.

RECRUITING
Registry status
Phase 3
Development phase
402 participants
Enrollment target
20
Study locations

Study Summary

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

Conditions Studied

Interventions

  • DRUG Darolutamide (Nubeqa, BAY1841788)

Study Locations (20)

California

  • City of Hope National Medical Center - Duarte
  • Tower Urology - Los Angeles
  • VA Greater Los Angeles Healthcare System - Los Angeles
  • Stanford Cancer Center Palo Alto - Palo Alto
  • San Diego Clinical Trials - San Diego
  • TOI Clinical Research - Whittier

Maryland

  • Anne Arundel Health System - Annapolis
  • Chesapeake Urology Associates - Towson - Baltimore
  • Johns Hopkins Hospital - Pulmonology - Baltimore
  • TidalHealth Peninsula Regional, Inc. - Oncology - Salisbury

Colorado

  • VA Eastern Colorado Health Care System - Aurora
  • The Urology Center Of Colorado - Denver

Florida

  • Boca Raton Regional Hospital - Oncology - Boca Raton
  • Advent Health Medical Group Urology - Orlando

Illinois

  • Jesse Brown VA Medical Center - Cardiology - Chicago
  • Illinois CancerCare - Peoria - Peoria

Alabama

  • Urology Centers of Alabama, PC - Homewood

Arizona

  • Ironwood Cancer and Research Centers - Chandler I - Chandler

Indiana

  • First Urology PSC - Jeffersonville

Trial Details

FieldValue
Enrollment Target 402 participants
Start Date 2020-10-20
Est. Completion 2028-06-26
Phase Phase 3

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT04464226

The ClinicalTrials.gov registry entry for NCT04464226 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 402 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,490-participant average among 615 other Cancer trials with a reported enrollment target (88% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which Darolutamide (Nubeqa, BAY1841788) is the first listed.

NCT04464226 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Maryland, Colorado.

Frequently Asked Questions

What is clinical trial NCT04464226 about?

NCT04464226 is a clinical study titled "Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer". The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previou...

What is the current status of trial NCT04464226?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 402 participants. The study started on 2020-10-20. Estimated completion is 2028-06-26.

What conditions does trial NCT04464226 study?

This clinical trial studies the following conditions: Cancer.

What interventions are being tested in trial NCT04464226?

The interventions under investigation include: Darolutamide (Nubeqa, BAY1841788) (DRUG).

Who is sponsoring clinical trial NCT04464226?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04464226 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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.