At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 76 enrolled
Drug / intervention
AC220drug
Likely dose
AC220 50mgfrom 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 I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC220 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia
In Brief
A Phase 1 clinical trial evaluating AC220 for Acute Myeloid Leukemia and 4 related conditions. Completed, enrolled 76 participants across 5 sites in 2 countries.
Detailed Summary
Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Leukemia, Myelodysplastic Syndrome, AML, MDS
CountriesGeorgia, United States
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedApr 2007
Primary CompletionMar 2009
Study CompletionDec 2009
TodayJul 2026
First PostedApr 19, 2007
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.2 years ago
Interventions
AC220drug
Powder in bottle formulation supplied as 50mg or 350 mg in glass, crimped serum vials. Requires reconstitution by a pharmacist, and must be stored securely and protected from light.