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NCT00830518 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome
A Phase 2 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT00830518: Completed Phase 2 study, sponsored by Millennium Pharmaceuticals.
NCT00830518 is a Phase 2 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00830518, a Phase 2 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Primary Outcome
Best ORR is defined as the number of participants with complete remission(CR) or partial remission(PR) assessed by the Investigator using modified AML/MDS International Working Group(IWG) Criteria. AML:CR=neutrophils \>1x10\^9/L, platelets \>100x10\^9/L, bone marrow blasts(BMB) \<5%, transfusion independent, no extramedullary disease(EMD); CRi=BMB \<5%, transfusion independent, no EMD; PR=neutrophils \>1x10\^9/L, platelets \>100x10\^9/L, BMB \>50% decrease and 5% to 25%, blasts \<5% with Auer ro
Interventions
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2009-02-10 |
| Est. Completion | 2011-07-04 |
| Phase | Phase 2 |
What the finished NCT00830518 record still lists
NCT00830518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Alisertib is the first listed.
NCT00830518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00830518 about?
NCT00830518 is a clinical study titled "A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome". This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
What is the current status of trial NCT00830518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2009-02-10. Estimated completion is 2011-07-04.
What interventions are being tested in trial NCT00830518?
The interventions under investigation include: Alisertib (DRUG).
Who is sponsoring clinical trial NCT00830518?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00830518's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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