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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 is a Phase 1 study that has completed, run by Jennerex Biotherapeutics. The registered enrollment target is 23 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00625456
The ClinicalTrials.gov registry entry for NCT00625456 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jennerex Biotherapeutics, which has 7 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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