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NCT00051467 · ClinicalTrials.gov registry record · Phase 3
A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
A Phase 3 study, sponsored by GenVec.
- Completed
- Registry status
- Phase 3
- Development phase
NCT00051467 is a Phase 3 study that has completed, run by GenVec.
The verdict
NCT00051467, a Phase 3 study, has completed, sponsored by GenVec.
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study Summary
The primary purpose of this study is to assess the safety and effectiveness of TNFerade™ Biologic when administered concurrently with 5-FU and radiation therapy as first-line treatment of unresectable locally advanced pancreatic cancer. TNFerade™ is a replication deficient adenovirus vector containing the gene for TNF-alpha controlled by a chemoradiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ Biologic is a novel way of selective delivery of TNF-alpha to tumor cells. TNFerade™ Biologic will be injected during five weekly injection sessions, concomitant with radiation and 5-FU. TNFerade™ Biologic will be administered by direct intratumoral injection using a percutaneous approach (PTA) or endoscopic ultrasound (EUS).
Interventions
- GENETIC TNFerade
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00051467
The ClinicalTrials.gov registry entry for NCT00051467 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is GenVec, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TNFerade is the first listed.
NCT00051467 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00051467 about?
NCT00051467 is a clinical study titled "A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer". The primary purpose of this study is to assess the safety and effectiveness of TNFerade™ Biologic when administered concurrently with 5-FU and radiation therapy as first-line treatment of unresectable locally advanced pancreatic cancer. TNFerade™ is a replication deficient adenovirus vector contain...
What is the current status of trial NCT00051467?
This trial is currently completed. It is a Phase 3 study.
What interventions are being tested in trial NCT00051467?
The interventions under investigation include: TNFerade (GENETIC).
Who is sponsoring clinical trial NCT00051467?
This trial is sponsored by GenVec, which has 7 total clinical trials registered on ClinicalTrials.gov.
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