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NCT01254890 · ClinicalTrials.gov registry record · Phase 1
Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01254890: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01254890 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01254890, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can control the disease in patients with AML or MDS. The safety of this drug combination will also be studied.
Primary Outcome
MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine
Interventions
- DRUG Azacitidine
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
What the finished NCT01254890 record still lists
NCT01254890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT01254890 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01254890 about?
NCT01254890 is a clinical study titled "Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome". The goal of this clinical research study is to learn if 5-azacitidine and sorafenib can control the disease in patients with AML or MDS. The safety of this drug combination will also be studied.
What is the current status of trial NCT01254890?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01254890?
The interventions under investigation include: Azacitidine (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT01254890?
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 NCT01254890's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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