NCT00989261

Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)

Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Compound AC220	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.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-09-28
• Completion: 2014-12-31
• First posted: 2009-10-05
• Last updated: 2019-12-11
• Results posted: 2019-11-29

Locations

85 sites across 9 countries: United States, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom