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NCT00625456 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors
A Phase 1 study, sponsored by Jennerex Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00625456: Completed Phase 1 study, sponsored by Jennerex Biotherapeutics.
NCT00625456 is a Phase 1 study that has completed, run by Jennerex Biotherapeutics. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00625456, a Phase 1 study, has completed, sponsored by Jennerex Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. These tumor types were selected because evidence of biological activity was observed in these tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in patients with metastatic disease to the liver. Patients will receive treatment at one of five dose levels in a sequential dose-escalating design.
Interventions
- DRUG Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-06 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT00625456 record still lists
NCT00625456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) is the first listed.
NCT00625456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00625456 about?
NCT00625456 is a clinical study titled "Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors". This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. These tumor types were sel...
What is the current status of trial NCT00625456?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2008-06. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00625456?
The interventions under investigation include: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) (DRUG).
Who is sponsoring clinical trial NCT00625456?
This trial is sponsored by Jennerex Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00625456's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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