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NCT00385580 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer

A Phase 2 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
94
Enrollment target

NCT00385580: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.

NCT00385580 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 94 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00385580, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
94 participants
Enrollment target

Study Summary

The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.

Primary Outcome

Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =\>30% in sum of longest diameter \[LD\] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease \[PD: =\>20% increase in sum of LD of a

Interventions

  • DRUG dasatinib

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2007-01
Est. Completion 2010-10
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00385580 record still lists

NCT00385580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).

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

NCT00385580 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00385580 about?

NCT00385580 is a clinical study titled "Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer". The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this tre...

What is the current status of trial NCT00385580?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2007-01. Estimated completion is 2010-10.

What interventions are being tested in trial NCT00385580?

The interventions under investigation include: dasatinib (DRUG).

Who is sponsoring clinical trial NCT00385580?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00385580's enrollment target sits among peer trials

94 764th of 2000 higher than 1,235 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 NCT00385580, the US trial registry maintained by the National Library of Medicine. NCT00385580 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.