Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Inclusion Criteria:

• Written informed consent prior to study-specific screening procedures
• Life expectancy of ≥ 60 days
• Eastern Cooperative Group (ECOG) performance status ≤ 2
• Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
• Negative serum pregnancy test (within 7 days of first dose)
• Negative urine pregnancy test immediately prior to first dose

Exclusion Criteria:

• Known HIV
• Psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
• Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
• Female patients who are pregnant or breast-feeding or patients of childbearing potential who are not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
• Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment
• Patient is unable to swallow capsules
• Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat

Other Protocol-defined inclusion/exclusion criteria may apply