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Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT04221542 · View on ClinicalTrials.gov ↗
Study Summary
The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG AMG 509
Study Locations (20)
California
- City of Hope National Medical Center — Duarte
- Providence Saint Jude Medical Center — Fullerton
- University of California San Francisco — San Francisco
North Carolina
- Duke University — Durham
- Wake Forest University Health Sciences — Winston-Salem
Pennsylvania
- Thomas Jefferson University — Philadelphia
- University of Pittsburgh Medical Center — Pittsburgh
Colorado
- Rocky Mountain Cancer Centers — Aurora
Connecticut
- Yale New Haven Hospital — New Haven
Georgia
- Emory University — Atlanta
Indiana
- Indiana University — Indianapolis
Kansas
- MidAmerica Cancer Care — Merriam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2020-03-04 |
| Est. Completion | 2032-03-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04221542
The ClinicalTrials.gov registry entry for NCT04221542 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 479 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 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 Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which Enzalutamide 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: NCT04221542 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, North Carolina, Pennsylvania. 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 NCT04221542 about?
NCT04221542 is a clinical study titled "Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer". The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 ar...
What is the current status of trial NCT04221542?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 479 participants. The study started on 2020-03-04. Estimated completion is 2032-03-21.
What conditions does trial NCT04221542 study?
This clinical trial studies the following conditions: Prostate 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 NCT04221542?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), AMG 509 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04221542?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04221542 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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