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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
  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:


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
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

  Hide Study Locations
Locations
United States, Illinois
University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)
Chicago, Illinois, United States, 60546
United States, Nebraska
Methodist Cancer Center Nebraska Methodist Hospital(2)
Omaha, Nebraska, United States, 68114
United States, New York
North Shore University Hospital North Shore Univ
Manhasset, New York, United States, 10030
Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)
New York, New York, United States, 10021
United States, Oregon
Oregon Health Sciences University Dept. of OHSU (2)
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern Medical Center Dept of Simmons Cancer Center
Dallas, Texas, United States, 75390-8527
MD Anderson Cancer Center/University of Texas Dept of MD Anderson (14)
Houston, Texas, United States, 77030-4009
Australia, New South Wales
Novartis Investigative Site
Gosford, New South Wales, Australia, 2250
Australia, Queensland
Novartis Investigative Site
Herston, Queensland, Australia, 4029
Australia, South Australia
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia, 3002
Novartis Investigative Site
Prahran, Victoria, Australia, 3181
Belgium
Novartis Investigative Site
Brugge, Belgium, 8000
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Liege, Belgium, 4000
France
Novartis Investigative Site
Bobigny Cedex, France, 93009
Novartis Investigative Site
Montpellier cedex 5, France, 34295
Novartis Investigative Site
Nantes, France, 44035
Novartis Investigative Site
Paris Cedex 4, France, 75181
Novartis Investigative Site
Toulouse cedex 9, France, 31059
Germany
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Köln, Germany, 50924
Novartis Investigative Site
Leipzig, Germany, 04103
Italy
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Roma, RM, Italy, 00133
Novartis Investigative Site
Udine, UD, Italy, 33100
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of, 137-701
Peru
Novartis Investigative Site
Surquillo, Lima, Peru, 34
Spain
Novartis Investigative Site
Barcelona, Cataluna, Spain, 08025
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya, Spain, 08907
Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Zürich, Switzerland, 8091
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Izmir, Turkey, 35340
United Kingdom
Novartis Investigative Site
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Novartis Investigative Site
Leeds, United Kingdom, LS9 7TF
Novartis Investigative Site
Liverpool, United Kingdom, L7 8XP
Novartis Investigative Site
London, United Kingdom, W12 0HS
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
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
Leukemia, Myeloid, Acute
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Panobinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014