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NCT04221542 · ClinicalTrials.gov registry record · Phase 1
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by Amgen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 479
- Enrollment target
- 20
- Study locations
NCT04221542 is a Phase 1 study of Prostate Cancer that is actively recruiting participants, run by Amgen. The registered enrollment target is 479 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT04221542, a Phase 1 study of Prostate Cancer, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 479 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 479 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (21% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT04221542 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, North Carolina, Pennsylvania.
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.
What interventions are being tested in trial NCT04221542?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), AMG 509 (DRUG).
Who is sponsoring clinical trial NCT04221542?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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.