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NCT00903461 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Radiation/Cetuximab Plus EGFR Antisense DNA for Head and Neck Squamous Cell Carcinoma
A Phase 1 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00903461: Clinical Trial Phase 1 study, sponsored by University of Pittsburgh.
NCT00903461 is a Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00903461, a Phase 1 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The Epidermal Growth Factor Receptor (EGFR) is highly expressed in SCCHN and its overexpression is associated with poor patient outcome. EGFR is a promising target of anticancer therapy. We have developed EGFR antisense DNA as a safe and potentially efficacious treatment for SCCHN as shown in a previous phase I study conducted at the University of Pittsburgh. Cetuximab (Erbitux or C225) is a chimerized EGFR monoclonal antibody that has produced positive results in a phase III trial in SCCHN when added to radiation therapy and was approved by the FDA for the treatment of locally advanced SCCHN. Radiation plus cetuximab is considered a standard treatment, especially for patients who are not good candidates for chemotherapy. In the current study, we plan to evaluate the addition of intratumoral EGFR antisense DNA (EGFR AS) to standard radiation with concurrent cetuximab in patients.
Primary Outcome
Change in tumor size based on CT or MRI scans of the same tumor(s) of the head and/or neck as compared to baseline measurement.
Interventions
- BIOLOGICAL EGFR Antisense DNA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-04 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
Why NCT00903461 stopped before completion
NCT00903461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which EGFR Antisense DNA is the first listed.
NCT00903461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00903461 about?
NCT00903461 is a clinical study titled "Safety and Efficacy of Radiation/Cetuximab Plus EGFR Antisense DNA for Head and Neck Squamous Cell Carcinoma". The Epidermal Growth Factor Receptor (EGFR) is highly expressed in SCCHN and its overexpression is associated with poor patient outcome. EGFR is a promising target of anticancer therapy. We have developed EGFR antisense DNA as a safe and potentially efficacious treatment for SCCHN as shown in a prev...
What is the current status of trial NCT00903461?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2012-04. Estimated completion is 2016-08.
What interventions are being tested in trial NCT00903461?
The interventions under investigation include: EGFR Antisense DNA (BIOLOGICAL).
Who is sponsoring clinical trial NCT00903461?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00903461's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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