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NCT00629057 · ClinicalTrials.gov registry record · Phase 1

A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer

A Phase 1 study, sponsored by Bavarian Nordic.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00629057 is a Phase 1 study that has completed, run by Bavarian Nordic. The registered enrollment target is 24 participants.

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The verdict

NCT00629057, a Phase 1 study, has completed, sponsored by Bavarian Nordic.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

BNIT-PR-001 is an open-label, multi-center, Phase I dosing evaluation trial of MVA-BN®-PRO in men with androgen-insensitive prostate cancer. Patients will have PSA recurrence after being treated with androgen suppression therapy or complete androgen blockade. The trial will consist of a treatment with up to 6 vaccinations with MVA-BN®-PRO at monthly intervals, followed by a 1-year follow-up phase. A vaccination may be 1, 2, or 4 injections of study vaccine. The study is designed to examine safety as well as the effect of three different doses on immune response.

Interventions

  • BIOLOGICAL MVA-BN-PRO

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2008-03
Est. Completion 2011-09
Phase Phase 1

Sponsor

Bavarian Nordic

41 total trials

What the Registry Record Tells You About NCT00629057

The ClinicalTrials.gov registry entry for NCT00629057 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bavarian Nordic, which has 41 total studies on file at ClinicalTrials.gov.

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

NCT00629057 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00629057 about?

NCT00629057 is a clinical study titled "A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer". BNIT-PR-001 is an open-label, multi-center, Phase I dosing evaluation trial of MVA-BN®-PRO in men with androgen-insensitive prostate cancer. Patients will have PSA recurrence after being treated with androgen suppression therapy or complete androgen blockade. The trial will consist of a treatment w...

What is the current status of trial NCT00629057?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-03. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00629057?

The interventions under investigation include: MVA-BN-PRO (BIOLOGICAL).

Who is sponsoring clinical trial NCT00629057?

This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.