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NCT01167816 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
A Phase 1 study, sponsored by University of Oklahoma.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01167816: Clinical Trial Phase 1 study, sponsored by University of Oklahoma.
NCT01167816 is a Phase 1 study that was terminated before completion, run by University of Oklahoma. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01167816, a Phase 1 study, was terminated before completion, sponsored by University of Oklahoma.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.
Primary Outcome
There will be 5 planned cohorts that will receive the escalating doses of azicitidine and gemcitabine. There will be at least 3 patients in each cohort
Interventions
- DRUG Vidaza
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
Why NCT01167816 stopped before completion
NCT01167816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Vidaza is the first listed.
NCT01167816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01167816 about?
NCT01167816 is a clinical study titled "Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer". The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.
What is the current status of trial NCT01167816?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2010-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01167816?
The interventions under investigation include: Vidaza (DRUG).
Who is sponsoring clinical trial NCT01167816?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01167816's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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