An Open-Label Phase I/II Study of XIAP Antisense AEG35156 Administered to Patients With Refractory/Relapsed AML in Combination With Chemotherapy
This is a phase I/II, single-arm, open-label, study to establish the recommended dose and
activity of AEG35156 administered as a daily x3 two-hour infusion prior to reinduction
chemotherapy with idarubicin and ara-C followed by weekly two-hour AEG35156 infusions.
Subjects eligible for study entry must have confirmed diagnosis of AML in first relapse
after an initial CR that lasted less than 6 months or primary refractory AML. Fixed dose of
idarubicin and ara-C will be given, plus one of eight doses of AEG35156: 12, 24, 48, 75,
110, 165, 250 and 350mg/m2. A maximum of 54 patients will be treated in cohorts of size 3,
starting at 12mg/m2, and not skipping any untried dose level when escalating. Following
dose escalation, approximately 20 patients will be treated at the best acceptable dose as
determined by the method of Thall and Cook (2004).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose at which AEG35156 when combined with fixed doses of ara-C and idarubicin, produces acceptable CR and toxicity rates as defined and observed at 30 days post-last dose
Jacques Jolivet, MD
Aegera Therapeutics Inc.
United States: Food and Drug Administration
|Northwestern Memorial Hospital||Chicago, Illinois 60611|
|UCLA Medical Center||Los Angeles, California 90095-7059|
|M.D. Anderson Cancer Center||Houston, Texas 77030|
|Norris Cancer Center - University of Southern California||Los Angeles, California 90033|
|Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center||Baltimore, Maryland 21231|