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NCT02440568 · ClinicalTrials.gov registry record · Phase 1
AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients
A Phase 1 study, sponsored by University of Illinois at Chicago.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02440568: Clinical Trial Phase 1 study, sponsored by University of Illinois at Chicago.
NCT02440568 is a Phase 1 study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02440568, a Phase 1 study, was terminated before completion, sponsored by University of Illinois at Chicago.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML).
Primary Outcome
The primary endpoint is determination of the optimally active and safe dose (OD) of Omacetaxine when added to the standard-of-care induction chemotherapy for AML and estimation of the efficacy and response rate. OD will be defined as a dose level at which fewer than 30% of patients experience hematologic toxicity and greater than 50% of patients achieve a CR (50% is an accepted CR rate in AML when using a single induction).
Interventions
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Omacetaxine mepesuccinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-06-05 |
| Est. Completion | 2018-11-30 |
| Phase | Phase 1 |
Why NCT02440568 stopped before completion
NCT02440568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Cytarabine is the first listed.
NCT02440568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02440568 about?
NCT02440568 is a clinical study titled "AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients". This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML).
What is the current status of trial NCT02440568?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2015-06-05. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT02440568?
The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Omacetaxine mepesuccinate (DRUG).
Who is sponsoring clinical trial NCT02440568?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02440568's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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