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NCT00433446 · ClinicalTrials.gov registry record · Phase 2

S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

A Phase 2 study, sponsored by SWOG Cancer Research Network.

Completed
Registry status
Phase 2
Development phase
62
Enrollment target

NCT00433446: Completed Phase 2 study, sponsored by SWOG Cancer Research Network.

NCT00433446 is a Phase 2 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00433446, a Phase 2 study, has completed, sponsored by SWOG Cancer Research Network.

COMPLETED
Registry status
Phase 2
Development phase
62 participants
Enrollment target

Study Summary

RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Primary Outcome

PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.

Interventions

  • BIOLOGICAL CNTO 328

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2007-04
Est. Completion 2011-07
Phase Phase 2
SWOG Cancer Research Network

270 total trials

What the finished NCT00433446 record still lists

NCT00433446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 1 intervention - of which CNTO 328 is the first listed.

NCT00433446 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00433446 about?

NCT00433446 is a clinical study titled "S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy". RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is...

What is the current status of trial NCT00433446?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2007-04. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00433446?

The interventions under investigation include: CNTO 328 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00433446?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00433446's enrollment target sits among peer trials

62 1016th of 2000 higher than 975 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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Source: ClinicalTrials.gov NCT00433446, the US trial registry maintained by the National Library of Medicine. NCT00433446 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.