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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: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will 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: 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • CRR [complete remission rate (CR/CRi)] [ Time Frame: June 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 88
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: Panobinostat Drug: Panobinostat/LBH589

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
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 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

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

  Show 39 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00880269     History of Changes
Other Study ID Numbers: CLBH589B2213, 2008-002983-32
Study First Received: March 30, 2009
Last Updated: April 18, 2013
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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013