A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies

A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies

This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies

Inclusion criteria:

• Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
• World Health Organization (WHO) performance status ≤ 2
• Patients who met protocol-specified hematologic and non-hematologic laboratory values
• Patients with adequate liver and renal function

Exclusion criteria:

• Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
• Peripheral neuropathy ≥ CTCAE grade 2
• Unresolved diarrhea ≥ CTCAE grade 2
• Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
• Female patients who were pregnant or breast feeding
• Patients who were unwilling to use an effective method of birth control
• Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
• Patients with another primary malignancy that required active intervention or were clinically significant