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

Completed · Phase 2

Conditions studied: Refractory Leukemia, Acute Myelogenous Leukemia

In brief

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.

Key facts

Study ID

NCT00880269

Run by

Novartis Pharmaceuticals

People needed

59

Starts

2009-08-01

Expected to finish

2012-02-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Chicago Medical Center Dept. of U. of Chicago Hosp(3) — Chicago, Illinois, United States
• Nebraska Methodist Hospital Nebraska Methodist Hospital(2) — Omaha, Nebraska, United States
• North Shore University Hospital North Shore Univ — Manhasset, New York, United States
• Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2) — New York, New York, United States
• Oregon Health Sciences University Dept. of OHSU (2) — Portland, Oregon, United States
• University of Texas Southwestern Medical Center Dept of Simmons Cancer Center — Dallas, Texas, United States
• University of Texas/MD Anderson Cancer Center Dept of MD Anderson (14) — Houston, Texas, United States
• Novartis Investigative Site — Gosford, New South Wales, Australia
• Novartis Investigative Site — Herston, Queensland, Australia
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — Fitzroy, Victoria, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Prahran, Victoria, Australia
• Novartis Investigative Site — Bruges, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Bobigny, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Leipzig, Germany
• Novartis Investigative Site — Roma, RM, Italy

Full record on ClinicalTrials.gov

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