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NCT00410865 · ClinicalTrials.gov registry record · Phase 1
Wild Type p53 Adenovirus for Oral Premalignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00410865: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00410865 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00410865, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Primary Objectives: 1. To determine the maximum tolerated dose and transduction efficiency of adenoviral mediated wild type p53 gene transfer in premalignancies of the upper aerodigestive tract. 2. To determine the efficacy of single agent adenoviral mediated wild type p53 gene transfer in reversing oral premalignancies.
Primary Outcome
MTD is defined as the highest dose level at which there are less than or equal to 1/6 patients with a dose limiting toxicity (DLT).
Interventions
- GENETIC INGN 201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2003-06 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
Why NCT00410865 stopped before completion
NCT00410865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which INGN 201 is the first listed.
NCT00410865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00410865 about?
NCT00410865 is a clinical study titled "Wild Type p53 Adenovirus for Oral Premalignancies". Primary Objectives: 1. To determine the maximum tolerated dose and transduction efficiency of adenoviral mediated wild type p53 gene transfer in premalignancies of the upper aerodigestive tract. 2. To determine the efficacy of single agent adenoviral mediated wild type p53 gene transfer in reversin...
What is the current status of trial NCT00410865?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2003-06. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00410865?
The interventions under investigation include: INGN 201 (GENETIC).
Who is sponsoring clinical trial NCT00410865?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00410865's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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