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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00880269
Registration number
NCT00880269
Ethics application status
Date submitted
30/03/2009
Date registered
13/04/2009
Date last updated
23/02/2017
Titles & IDs
Public title
Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
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Scientific title
A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
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Secondary ID [1]
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2008-002983-32
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Secondary ID [2]
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CLBH589B2213
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Refractory Leukemia
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Acute Myelogenous Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 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.
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.
Treatment: Drugs: Panobinostat/LBH589
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Best Response as Per Investigator Assessment by Stratum (FAS)
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Assessment method [1]
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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.
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Timepoint [1]
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6 cycles of treatment with a 28-day treatment cycle (Day 168)
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Secondary outcome [1]
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Partial Response Measured in Stratum A and B
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Assessment method [1]
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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)
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Timepoint [1]
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6 treatment cycles (28-day/treatment cycle)
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Secondary outcome [2]
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Time to Remission Measured in Stratum A and B
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Assessment method [2]
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Timepoint [2]
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6 treatment cycles (28-day/treatment cycle)
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Secondary outcome [3]
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Duration of Remission Measured in Stratum A and B
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Assessment method [3]
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Timepoint [3]
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6 treatment cycles (28-day/treatment cycle)
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Secondary outcome [4]
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Event-free Survival Measured in Stratum A and B
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Assessment method [4]
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Timepoint [4]
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6 treatment cycles (28-day/treatment cycle)
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Secondary outcome [5]
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Overall Survival Measured in Stratum A and B
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Assessment method [5]
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Timepoint [5]
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6 treatment cycles (28-day/treatment cycle)
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Eligibility
Key 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
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Minimum age
18
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2012
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Sample size
Target
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Gosford
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Recruitment hospital [2]
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Novartis Investigative Site - Herston
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Recruitment hospital [3]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [4]
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Novartis Investigative Site - Fitzroy
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Recruitment hospital [5]
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Novartis Investigative Site - Parkville
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Recruitment hospital [6]
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Novartis Investigative Site - Prahran
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3002 - Parkville
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Recruitment postcode(s) [6]
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3181 - Prahran
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Recruitment outside Australia
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United States of America
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Illinois
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United States of America
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Nebraska
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United States of America
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New York
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United States of America
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Oregon
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United States of America
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Texas
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Belgium
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Brugge
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Belgium
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Gent
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Belgium
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Liege
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France
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Bobigny Cedex
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France
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Montpellier cedex 5
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France
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Nantes
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France
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Paris Cedex 4
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France
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Toulouse cedex 9
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Germany
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Nordrhein-Westfalen
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Germany
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Frankfurt
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Germany
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Leipzig
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Italy
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RM
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Italy
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UD
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Korea, Republic of
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Korea
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Peru
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Lima
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Spain
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Catalunya
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Spain
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Barcelona
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Switzerland
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Bern
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Switzerland
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Zürich
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Turkey
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Ankara
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Turkey
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Balcova / Izmir
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United Kingdom
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Scotland
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United Kingdom
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West Yorkshire
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United Kingdom
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Liverpool
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00880269
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00880269
Download to PDF