At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 333 enrolled
Drug / intervention
Compound AC220drug
Likely dose
Compound AC220 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations
In Brief
A Phase 2 clinical trial evaluating Compound AC220 for Acute Myeloid Leukemia. Completed, enrolled 333 participants across 85 sites in 9 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesCanada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartNov 2009
Primary CompletionSep 2012
Study CompletionDec 2014
TodayJul 2026
First PostedOct 5, 2009
Enrollment StartNov 1, 2009
Primary CompletionSep 28, 2012
Study CompletionDec 31, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.7 years ago
Interventions
Compound AC220drug
Precomplexed powder in bottle formulation supplied as 200 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.