Status:
COMPLETED
Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Refractory Leukemia
Acute Myelogenous Leukemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00880269
Start Date
August 1 2009
End Date
February 1 2012
Last Update
February 23 2017
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)
Chicago, Illinois, United States, 60637
2
Nebraska Methodist Hospital Nebraska Methodist Hospital(2)
Omaha, Nebraska, United States, 68114
3
North Shore University Hospital North Shore Univ
Manhasset, New York, United States, 10030
4
Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)
New York, New York, United States, 10065