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Phase I/II study to assess the safety, efficacy, and pharmacokinetics of barasertib (AZD1152) in patients with advanced acute myeloid leukemia
Blood, 10/10/2011
Clinical Article
Lowenberg B et al. – The MTD of barasertib was 1200 mg in patients with relapsed or newly diagnosed AML. Toxicity was manageable and barasertib treatment resulted in an overall hematological response rate of 25%.
Methods- Part A determined the MTD of barasertib administered as continuous 7-day infusion every 21 days
- In part B, efficacy of barasertib was evaluated at MTD
- In part A, 32 patients were treated with barasertib 50 mg (n=3), 100 mg (n=3), 200 mg (n=3), 400 mg (n=4), 800 mg (n=7), 1200 (n=6) and 1600 mg (n=6)
- Dose-limiting toxicities (DLTs; stomatitis/mucosal inflammation events) reported in 800 mg (n=1), 1200 mg (n=1) and 1600 mg (n=2) groups
- In each part of study, 8/32 patients had hematological response (Cheson AML criteria)
- Most commonly reported Grade ≥3 events were febrile neutropenia (24 patients) and stomatitis/mucosal inflammation (16 patients)
