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NCT00443261 · ClinicalTrials.gov registry record · Phase 1
Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study, sponsored by University of Kansas Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT00443261: Clinical Trial Phase 1 study, sponsored by University of Kansas Medical Center.
NCT00443261 is a Phase 1 study that was terminated before completion, run by University of Kansas Medical Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00443261, a Phase 1 study, was terminated before completion, sponsored by University of Kansas Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN).
Primary Outcome
Although response is not the primary endpoint of this trial, patients with measurable disease will by assessed by standard criteria. For the purpose of this study, patients should be re-evaluated every 8 weeks by imaging study. In addition to baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response.
Interventions
- DRUG Cisplatin
- DRUG Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2007-02 |
| Est. Completion | 2008-06 |
| Phase | Phase 1 |
Why NCT00443261 stopped before completion
NCT00443261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.
NCT00443261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00443261 about?
NCT00443261 is a clinical study titled "Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN).
What is the current status of trial NCT00443261?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2007-02. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00443261?
The interventions under investigation include: Cisplatin (DRUG), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT00443261?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00443261's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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