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NCT00477087 · ClinicalTrials.gov registry record · Phase 2

Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer

A Phase 2 study, sponsored by Stanford University.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT00477087: Clinical Trial Phase 2 study, sponsored by Stanford University.

NCT00477087 is a Phase 2 study that was terminated before completion, run by Stanford University. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00477087, a Phase 2 study, was terminated before completion, sponsored by Stanford University.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.

Primary Outcome

Assessed as the time from the 1st dose of study drug to death or disease progression (increase \>25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of \>20% KPS)

Interventions

  • DRUG Mitoxantrone
  • DRUG GM-CSF

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2006-07
Est. Completion 2010-01
Phase Phase 2
Stanford University

1,744 total trials

Why NCT00477087 stopped before completion

NCT00477087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Mitoxantrone is the first listed.

NCT00477087 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00477087 about?

NCT00477087 is a clinical study titled "Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer". The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.

What is the current status of trial NCT00477087?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2006-07. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00477087?

The interventions under investigation include: Mitoxantrone (DRUG), GM-CSF (DRUG).

Who is sponsoring clinical trial NCT00477087?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00477087's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 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 NCT00477087, the US trial registry maintained by the National Library of Medicine. NCT00477087 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.