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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00880269
First received: March 30, 2009
Last updated: April 18, 2013
Last verified: April 2013

March 30, 2009
April 18, 2013
August 2009
February 2012   (final data collection date for primary outcome measure)
CRR [complete remission rate (CR/CRi)] [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
CRR [complete remission rate (CR/CRi)] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00880269 on ClinicalTrials.gov Archive Site
  • To assess partial remission [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
  • Time to remission and duration of remission [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: Jan 2012 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Jan 2012 ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
  • To assess partial remission [ Time Frame: duration of study/after end of study ] [ Designated as safety issue: No ]
  • Time to remission and duration of remission [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: duration of study/after end of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: duration of study/after end of study ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

This study will evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.

Not Provided
Interventional
Phase 2
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Refractory Leukemia
  • Acute Myelogenous Leukemia
Drug: Panobinostat/LBH589
Experimental: Panobinostat
Intervention: Drug: Panobinostat/LBH589
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
February 2012
February 2012   (final data collection date for primary outcome measure)

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

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   United Kingdom,   Australia,   Belgium,   France,   Italy,   Korea, Republic of,   Peru,   Spain,   Switzerland,   Turkey
 
NCT00880269
CLBH589B2213, 2008-002983-32
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP