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NCT01249430 · ClinicalTrials.gov registry record · Phase 1
Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01249430: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01249430 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01249430, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of azacitidine when given together with mitoxantrone, etoposide phosphate, and cytarabine in treating patients with acute myeloid leukemia that has returned after a period of improvement or does not respond to treatment. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone, etoposide phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Azacitidine may help mitoxantrone, etoposide phosphate, and cytarabine work better by making cancer cells more sensitive to the drugs.
Primary Outcome
Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.
Interventions
- DRUG Azacitidine
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- DRUG Etoposide Phosphate
- DRUG Mitoxantrone Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-01-20 |
| Est. Completion | 2013-05-24 |
| Phase | Phase 1 |
What the finished NCT01249430 record still lists
NCT01249430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Azacitidine is the first listed.
NCT01249430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01249430 about?
NCT01249430 is a clinical study titled "Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia". This phase I trial studies the side effects and best dose of azacitidine when given together with mitoxantrone, etoposide phosphate, and cytarabine in treating patients with acute myeloid leukemia that has returned after a period of improvement or does not respond to treatment. Azacitidine may stop ...
What is the current status of trial NCT01249430?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-01-20. Estimated completion is 2013-05-24.
What interventions are being tested in trial NCT01249430?
The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Etoposide Phosphate (DRUG), Mitoxantrone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01249430?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01249430's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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