Woman and Man
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Extract
The primary objectives of the Phase 1 portion of Study DACOGENAML2004 are: •to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2 per day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2 per day on Days 1-5 of a 28-day cycle. •to determine PK parameters including maximum plasma concentration (Cmax), Area under the concentration x time curve (AUC), time to maximum plasma concentration (tmax), and clearance (Cl) of decitabine on Day 5 of Cycle 1. The primary objective of the Phase 2 portion of Study DACOGENAML2004 is to determine the response rate (CR + CRi) in children with relapsed or refractory AML when treated with DACOGEN 20 mg/m2 per day on Days 1-5 followed by cytarabine at the determined MTD on Days 8-12 for up to 4 cycles of treatment.
Inclusion criteria
- Relapsed or refractory acute myeloid leukemia