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Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
NCT04464226 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2028-06-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04464226
The ClinicalTrials.gov registry entry for NCT04464226 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 402 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04464226 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Maryland, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04464226?
The interventions under investigation include: Darolutamide (Nubeqa, BAY1841788) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04464226?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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