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NCT00082134 · ClinicalTrials.gov registry record · Phase 2

Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel

A Phase 2 study, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00082134: Completed Phase 2 study, sponsored by Genzyme, a Sanofi Company.

NCT00082134 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00082134, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.

Interventions

  • DRUG ILX651

Trial Details

FieldValue
Enrollment Target 40 participants
Est. Completion 2005-12
Phase Phase 2
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00082134 record still lists

NCT00082134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which ILX651 is the first listed.

NCT00082134 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00082134 about?

NCT00082134 is a clinical study titled "Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel". This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV ...

What is the current status of trial NCT00082134?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. Estimated completion is 2005-12.

What interventions are being tested in trial NCT00082134?

The interventions under investigation include: ILX651 (DRUG).

Who is sponsoring clinical trial NCT00082134?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00082134's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 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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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT00082134, the US trial registry maintained by the National Library of Medicine. NCT00082134 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.