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NCT04662580 · ClinicalTrials.gov registry record · Phase 1
ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
A Phase 1 study of Metastatic Prostate Cancer, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 183
- Enrollment target
- 12
- Study locations
NCT04662580: Active Phase 1 study of Metastatic Prostate Cancer, sponsored by Janssen Research & Development.
NCT04662580 is a Phase 1 study of Metastatic Prostate Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 183 participants, roughly in line with the 182-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target. The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04662580, a Phase 1 study of Metastatic Prostate Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 183 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is a phase 1 study to assess the safety and tolerability of ARX517 as monotherapy or combination therapy in adult subjects with metastatic prostate cancer (mPC).
Primary Outcome
Incidence and severity of adverse events or serious adverse events of ARX517 alone or in combination with ARPIs will be assessed to determine the safety and tolerability of the treatment using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE).
Conditions Studied
Interventions
- DRUG Apalutamide
- DRUG Prednisone
- DRUG Abiraterone acetate
- DRUG ARX517
Study Locations (12)
California
- UC San Diego Moores Cancer Center - La Jolla
- University of California, Los Angeles School of Medicine - Los Angeles
- UCSF Medical Center at Mission Bay - San Francisco
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Indiana
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Missouri
- Washington University St. Louis School Medicine Siteman Cancer Center - St Louis
Nebraska
- GU Research Network - Omaha
New York
- Weill Cornell Medical College - New York
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04662580 still lists
NCT04662580 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 182-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target.
The record links to 1 condition, with Metastatic Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Apalutamide is the first listed.
NCT04662580 lists 12 locations in 10 states (California, Georgia, Indiana).
Frequently Asked Questions
What is clinical trial NCT04662580 about?
NCT04662580 is a clinical study titled "ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer". This is a phase 1 study to assess the safety and tolerability of ARX517 as monotherapy or combination therapy in adult subjects with metastatic prostate cancer (mPC).
What is the current status of trial NCT04662580?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 183 participants. The study started on 2021-05-03. Estimated completion is 2026-12-31.
What conditions does trial NCT04662580 study?
This clinical trial studies the following conditions: Metastatic Prostate Cancer.
What interventions are being tested in trial NCT04662580?
The interventions under investigation include: Apalutamide (DRUG), Prednisone (DRUG), Abiraterone acetate (DRUG), ARX517 (DRUG).
Who is sponsoring clinical trial NCT04662580?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04662580 being conducted?
This trial has 12 study locations across California, Georgia, Indiana, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04662580's enrollment target sits among peer trials
183 11th of 41 higher than 31 of 41 other Metastatic Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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