Overview

Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
Summary
This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Panobinostat
Criteria
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 interfered 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 were pregnant or breast-feeding or patients of childbearing
potential who were 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) were women of childbearing potential who were
not willing to use a double method of contraception, one of which included a condom,
during the study and for 3 months after the end of treatment

- Patient 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