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Efficacy and Safety of Panobinostat (LBH589) 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: January 8, 2017
Last verified: January 2017
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ( Novartis Pharmaceuticals ):

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) ]
    Response to treatment was defined as complete remission rate (CRR). CRR is complete remission (CR) and morphologic CR with incomplete blood count recovery (residual neutropenia or thrombocytopenia) (CRi). To stop or to proceed with Stage 2 of a given stratum of the Simon's optimal 2-stage design was based on the number of patients with CR/CRi and a safety evaluation of the patients from Stage 1 in that stratum. If early results clearly indicated that the drug was not active or worthy of further investigation, enrollment of that particular stratum would be terminated. CR and CRi were assessed by the Investigator according to IWG response Criteria for AML (Cheson et al 2003). As per protocol we would continue to stage II if ≥ 4 patients out of 26 patients enrolled to stage I had a CR or a CRi. As per response observed there was only 1 patient with CR/CRi in stratum A and 2 patients with CR/CRi in Stratum B.


Secondary Outcome Measures:
  • Partial Response Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
    As predefined in the study's protocol, stage II was not pursued due to lack of activity (at end of stage I less than 4 patients in each stratum with CR/CRi)

  • Time to Remission Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
  • Duration of Remission Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
  • Event-free Survival Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
  • Overall Survival Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]

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)
Sexes Eligible for Study:   All
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

  Hide Study Locations
Locations
United States, Illinois
University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)
Chicago, Illinois, United States, 60637
United States, Nebraska
Nebraska Methodist Hospital 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)
NY, New York, United States, 10065
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
University of Texas/MD Anderson Cancer Center 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
Fitzroy, Victoria, Australia, 3065
Novartis Investigative Site
Parkville, 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
Koeln, Nordrhein-Westfalen, Germany, 50937
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Leipzig, Germany, 04103
Italy
Novartis Investigative Site
Roma, RM, Italy, 00133
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Udine, UD, Italy, 33100
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 06591
Peru
Novartis Investigative Site
Surquillo, Lima, Peru, 34
Spain
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site
Barcelona, Spain, 08041
Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Zürich, Switzerland, 8091
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Balcova / Izmir, Turkey, 35340
United Kingdom
Novartis Investigative Site
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Novartis Investigative Site
Liverpool, United Kingdom, L7 8XP
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Novartis Investigative Site
London, United Kingdom, W12 0HS
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 ( EudraCT Number )
Study First Received: March 30, 2009
Results First Received: July 21, 2016
Last Updated: January 8, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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 21, 2017