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NCT04631601 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT04631601: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT04631601 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04631601, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).
Primary Outcome
DLTs were defined as any adverse event (AE) (per Common Terminology Criteria for Adverse Events (CTCAE) v5: Grade 5=Death, Grade 4=Life-threatening, Grade 3=Moderate) occurring within 28 days of the first AMG 160 dose, possibly related to the treatment, including: * Grade 5 toxicity * Grade 4 thrombocytopenia * Grade 3 thrombocytopenia with significant hemorrhage * Grade 4 neutropenia \> 5 days * Febrile neutropenia * Grade 3 anemia requiring transfusion * Grade ≥3 non-hematologic toxicity (wit
Interventions
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG AMG 404
- DRUG Acapatamab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2023-10-23 |
| Phase | Phase 1 |
Why NCT04631601 stopped before completion
NCT04631601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Enzalutamide is the first listed.
NCT04631601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04631601 about?
NCT04631601 is a clinical study titled "Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)". This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).
What is the current status of trial NCT04631601?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2021-01-15. Estimated completion is 2023-10-23.
What interventions are being tested in trial NCT04631601?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), AMG 404 (DRUG), Acapatamab (DRUG).
Who is sponsoring clinical trial NCT04631601?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04631601's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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