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NCT01169584 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors in Pediatric Patients
A Phase 1 study, sponsored by Jennerex Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01169584 is a Phase 1 study that has completed, run by Jennerex Biotherapeutics. The registered enrollment target is 6 participants.
The verdict
NCT01169584, a Phase 1 study, has completed, sponsored by Jennerex Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy and/or the patient does not tolerate standard therapies. Tumors are likely to include neuroblastoma, lymphoma, Wilms' tumor, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcomas, and malignant peripheral nerve sheath tumors. Benign tumors are excluded. These tumor types were selected because evidence of biological activity was observed in cancer cells lines and ex vivo infected primary human tissue samples, specifically pediatric cancer types such as sarcomas and neuroblastomas.
Interventions
- DRUG Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01169584
The ClinicalTrials.gov registry entry for NCT01169584 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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.
NCT01169584 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01169584 about?
NCT01169584 is a clinical study titled "Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors in Pediatric Patients". This is a Phase I, open-label, dose-escalation trial of JX-594 (Pexa-Vec) in pediatric patients with advanced/metastatic, unresectable solid tumors refractory to standard therapy and/or the patient does not tolerate standard therapies. Tumors are likely to include neuroblastoma, lymphoma, Wilms' tum...
What is the current status of trial NCT01169584?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2010-08. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01169584?
The interventions under investigation include: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) (DRUG).
Who is sponsoring clinical trial NCT01169584?
This trial is sponsored by Jennerex Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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