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NCT00496535 · ClinicalTrials.gov registry record · Phase 1
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
A Phase 1 study, sponsored by GenVec.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00496535 is a Phase 1 study that has completed, run by GenVec.
The verdict
NCT00496535, a Phase 1 study, has completed, sponsored by GenVec.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on a "week-on/week-off" schedule. The primary objective of the second phase II is to determine the locoregional control rate at 24 months.
Interventions
- DRUG TNFerade biologic
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00496535
The ClinicalTrials.gov registry entry for NCT00496535 describes a study currently listed as completed, categorized as Phase 1. 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 biologic is the first listed.
NCT00496535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00496535 about?
NCT00496535 is a clinical study titled "A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer". The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head ...
What is the current status of trial NCT00496535?
This trial is currently completed. It is a Phase 1 study.
What interventions are being tested in trial NCT00496535?
The interventions under investigation include: TNFerade biologic (DRUG).
Who is sponsoring clinical trial NCT00496535?
This trial is sponsored by GenVec, which has 7 total clinical trials registered on ClinicalTrials.gov.
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