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
This is a multi-center clinical study conducted in the USA and possibly two international
sites. It is open-label, dose escalation study designed to characterize the safety,
tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered AC220
as a single agent given daily for 14 days. Cohorts of 3 patients receive AC220 until dose
limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD
is determined. Patients not experiencing DLT or significant disease progression at Day 15
may continue receiving AC220 at the discretion of the Investigator and Sponsor. FLT3
positive and negative patients are allowed to participate.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
The primary objectives of this study are to:•Determine the safety and tolerability, including dose limiting toxicity (DLT), of oral AC220 when administered daily to patients with relapsed or treatment-refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
6 months
Yes
Guy Gammon, MB BS, MRCP
Study Director
Interim Chief Medical Officer, Ambit Biosciences Corporation
United States: Food and Drug Administration
CP0001
NCT00462761
January 2007
December 2009
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |