A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

ClinicalTrials.gov ID: NCT00385827

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Official title

A Phase 2, Multicenter, Open-Label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT00385827
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: Centocor, Inc.; Industry
Enrollment: 106 participants

Conditions and interventions

Conditions

Cancer, Prostate

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2006 (Type not available)
Primary completion: Nov 2008 (Actual)
Completion: Nov 2008 (Actual)
Last update posted: Aug 20, 2014

2006 – 2008

United States locations

U.S. sites: 11
U.S. states: 10
U.S. cities: 11

Facility	City	State	ZIP	Site status
Not listed	Norwalk	Connecticut	—	—
Not listed	Port Saint Lucie	Florida	—	—
Not listed	Atlanta	Georgia	—	—
Not listed	Shreveport	Louisiana	—	—
Not listed	Baltimore	Maryland	—	—
Not listed	St Louis	Missouri	—	—
Not listed	New York	New York	—	—
Not listed	Philadelphia	Pennsylvania	—	—
Not listed	Charleston	South Carolina	—	—
Not listed	North Charleston	South Carolina	—	—
Not listed	Milwaukee	Wisconsin	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00385827, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 20, 2014 · Synced Nov 12, 2026