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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
  Purpose
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.

Condition Intervention Phase
Refractory Leukemia
Acute Myelogenous Leukemia
Drug: Panobinostat/LBH589
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 59
Study Start Date: August 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Drug: Panobinostat/LBH589

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880269

  Show 40 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00880269     History of Changes
Other Study ID Numbers: CLBH589B2213  2008-002983-32 
Study First Received: March 30, 2009
Results First Received: July 21, 2016
Last Updated: July 21, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Acute myeloid leukemia
AML
relapsed acute myeloid leukemia
refractory AML
refractory de novo AML
refractory secondary AML
secondary AML
AML following myelodysplastic syndrome (MDS)
AML following antecedent hematological disorder (AHD)
AML resistant to therapy

Additional relevant MeSH terms:
Leukemia
Neoplasm Metastasis
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016