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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: July 21, 2016
Last verified: July 2016
History of Changes

March 30, 2009
July 21, 2016
August 2009
February 2012   (final data collection date for primary outcome measure)
Best Response as Per Investigator Assessment by Stratum (FAS) [ Time Frame: 6 cycles of treatment with a 28-day treatment cycle (Day 168) ] [ Designated as safety issue: No ]
This study followed Simon's optimal 2-stage design in each stratum, allowing the study to stop due to futility at the end of stage 1. The results of this endpoint determine the continuation of stage 2 of the study.
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
  • Partial Response Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ] [ Designated as safety issue: No ]
  • Time to Remission Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ] [ Designated as safety issue: No ]
  • Duration of Remission Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ] [ Designated as safety issue: No ]
  • Event-free Survival Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ] [ Designated as safety issue: No ]
  • Overall Survival Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ] [ 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 was to 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Refractory Leukemia
  • Acute Myelogenous Leukemia
Drug: Panobinostat/LBH589
  • Experimental: Stratum A
    patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
    Intervention: Drug: Panobinostat/LBH589
  • Experimental: Stratum B
    patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
    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
59
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 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
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   France,   Germany,   Italy,   Korea, Republic of,   Peru,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT00880269
CLBH589B2213, 2008-002983-32
No
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2016

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