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NCT01893320 · ClinicalTrials.gov registry record · Phase 1
Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT01893320: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01893320 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893320, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the combination of vosaroxin and decitabine can help to control AML or MDS. The safety of these drugs will also be studied.
Primary Outcome
Maximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which \<33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on stud
Interventions
- DRUG Decitabine
- DRUG Vosaroxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2013-07-18 |
| Est. Completion | 2021-01-11 |
| Phase | Phase 1 |
What the finished NCT01893320 record still lists
NCT01893320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT01893320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01893320 about?
NCT01893320 is a clinical study titled "Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome". The goal of this clinical research study is to learn if the combination of vosaroxin and decitabine can help to control AML or MDS. The safety of these drugs will also be studied.
What is the current status of trial NCT01893320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2013-07-18. Estimated completion is 2021-01-11.
What interventions are being tested in trial NCT01893320?
The interventions under investigation include: Decitabine (DRUG), Vosaroxin (DRUG).
Who is sponsoring clinical trial NCT01893320?
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 NCT01893320's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 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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