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NCT00429312 · ClinicalTrials.gov registry record · Phase 1

A Study of Recombinant Vaccinia Virus to Treat Malignant Melanoma

A Phase 1 study, sponsored by Jennerex Biotherapeutics.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT00429312: Completed Phase 1 study, sponsored by Jennerex Biotherapeutics.

NCT00429312 is a Phase 1 study that has completed, run by Jennerex Biotherapeutics. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00429312, a Phase 1 study, has completed, sponsored by Jennerex Biotherapeutics.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

The purpose of this research study is to find out whether JX-594 (Pexa-Vec) is safe and effective for treating surgically unresectable malignant melanoma.

Primary Outcome

Response was evaluated at the participant level based on the sum of the longest diameters of the injected target tumors. Tumor assessments were performed using RECIST criteria. Complete response (CR): all lesions disappear; Partial response (PR): maximum diameter decrease of \> 30% of the longest diameter (LD) of target lesions using the baseline LD; Progressive disease (PD): increase of \>20% in the sum of LD target lesions using the smallest sum LD recorded since treatment started; Stable dise

Interventions

  • BIOLOGICAL JX-594

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2007-03
Est. Completion 2009-12
Phase Phase 1
Jennerex Biotherapeutics

7 total trials

What the finished NCT00429312 record still lists

NCT00429312 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which JX-594 is the first listed.

NCT00429312 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00429312 about?

NCT00429312 is a clinical study titled "A Study of Recombinant Vaccinia Virus to Treat Malignant Melanoma". The purpose of this research study is to find out whether JX-594 (Pexa-Vec) is safe and effective for treating surgically unresectable malignant melanoma.

What is the current status of trial NCT00429312?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2007-03. Estimated completion is 2009-12.

What interventions are being tested in trial NCT00429312?

The interventions under investigation include: JX-594 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00429312?

This trial is sponsored by Jennerex Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00429312's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00429312, the US trial registry maintained by the National Library of Medicine. NCT00429312 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.