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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: Completed Phase 3 study, sponsored by GenVec.
NCT00051467 is a Phase 3 study that has completed, run by GenVec. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00051467 record still lists
NCT00051467 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 1 intervention - of which TNFerade is the first listed.
NCT00051467 does not publish any study locations in the registry export this page uses.
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.