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NCT00545766 · ClinicalTrials.gov registry record · Phase 2

Vinflunine in Hormone Refractory Prostate Cancer (HRPC)

A Phase 2 study, sponsored by SCRI Development Innovations.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT00545766: Completed Phase 2 study, sponsored by SCRI Development Innovations.

NCT00545766 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00545766, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

Currently, there are no established 2nd-line or salvage chemotherapy regimens for patients with HRPC, many of whom retain an excellent performance status. The antitumor characteristics and toxicity profile of vinflunine make it an ideal agent to be investigated in this setting. In this Phase II trial, we plan to evaluate the efficacy, toxicity, and feasibility of administering IV vinflunine at a dose of 320 mg/m2 q3w as salvage chemotherapy in patients with HRPC. The patients will be evaluated for response, survival, and toxicity. If significant antitumor activity is demonstrated, further evaluation of this agent either alone or combination regimens and at earlier stages of disease will be indicated.

Primary Outcome

Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.

Interventions

  • DRUG Vinflunine

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2007-05
Est. Completion 2009-01
Phase Phase 2
SCRI Development Innovations

146 total trials

What the finished NCT00545766 record still lists

NCT00545766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).

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

NCT00545766 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00545766 about?

NCT00545766 is a clinical study titled "Vinflunine in Hormone Refractory Prostate Cancer (HRPC)". Currently, there are no established 2nd-line or salvage chemotherapy regimens for patients with HRPC, many of whom retain an excellent performance status. The antitumor characteristics and toxicity profile of vinflunine make it an ideal agent to be investigated in this setting. In this Phase II tria...

What is the current status of trial NCT00545766?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2007-05. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00545766?

The interventions under investigation include: Vinflunine (DRUG).

Who is sponsoring clinical trial NCT00545766?

This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00545766's enrollment target sits among peer trials

41 1352nd of 2000 higher than 639 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 NCT00545766, the US trial registry maintained by the National Library of Medicine. NCT00545766 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.