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NCT00989261 · ClinicalTrials.gov registry record · Phase 2
Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)
A Phase 2 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 333
- Enrollment target
NCT00989261: Completed Phase 2 study, sponsored by Daiichi Sankyo.
NCT00989261 is a Phase 2 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 333 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00989261, a Phase 2 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 333 participants
- Enrollment target
Study Summary
AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).
Primary Outcome
Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD\[+\] Participants) Modified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria
Interventions
- DRUG Compound AC220
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-12-31 |
| Phase | Phase 2 |
What the finished NCT00989261 record still lists
NCT00989261 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 1 intervention - of which Compound AC220 is the first listed.
NCT00989261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00989261 about?
NCT00989261 is a clinical study titled "Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)". AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).
What is the current status of trial NCT00989261?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 333 participants. The study started on 2009-11. Estimated completion is 2014-12-31.
What interventions are being tested in trial NCT00989261?
The interventions under investigation include: Compound AC220 (DRUG).
Who is sponsoring clinical trial NCT00989261?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00989261's enrollment target sits among peer trials
333 144th of 2000 higher than 1,857 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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