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NCT00385827 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)
A Phase 2 study, sponsored by Centocor.
- Terminated
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
NCT00385827: Clinical Trial Phase 2 study, sponsored by Centocor.
NCT00385827 is a Phase 2 study that was terminated before completion, run by Centocor. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00385827, a Phase 2 study, was terminated before completion, sponsored by Centocor.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).
Primary Outcome
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or s
Interventions
- DRUG Prednisone
- DRUG Siltuximab
- DRUG Mitoxantrone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
Why NCT00385827 stopped before completion
NCT00385827 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT00385827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00385827 about?
NCT00385827 is a clinical study titled "A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)". The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (ab...
What is the current status of trial NCT00385827?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2006-11. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00385827?
The interventions under investigation include: Prednisone (DRUG), Siltuximab (DRUG), Mitoxantrone (DRUG).
Who is sponsoring clinical trial NCT00385827?
This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00385827's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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