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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Scientific title
A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
Secondary ID [1] 0 0
2008-002983-32
Secondary ID [2] 0 0
CLBH589B2213
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory Leukemia 0 0
Acute Myelogenous Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best Response as Per Investigator Assessment by Stratum (FAS)
Timepoint [1] 0 0
6 cycles of treatment with a 28-day treatment cycle (Day 168)
Secondary outcome [1] 0 0
Partial Response Measured in Stratum A and B
Timepoint [1] 0 0
6 treatment cycles (28-day/treatment cycle)
Secondary outcome [2] 0 0
Time to Remission Measured in Stratum A and B
Timepoint [2] 0 0
6 treatment cycles (28-day/treatment cycle)
Secondary outcome [3] 0 0
Duration of Remission Measured in Stratum A and B
Timepoint [3] 0 0
6 treatment cycles (28-day/treatment cycle)
Secondary outcome [4] 0 0
Event-free Survival Measured in Stratum A and B
Timepoint [4] 0 0
6 treatment cycles (28-day/treatment cycle)
Secondary outcome [5] 0 0
Overall Survival Measured in Stratum A and B
Timepoint [5] 0 0
6 treatment cycles (28-day/treatment cycle)

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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Gosford
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [3] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [4] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [5] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [6] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3002 - Parkville
Recruitment postcode(s) [6] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Nebraska
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Belgium
State/province [6] 0 0
Brugge
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Liege
Country [9] 0 0
France
State/province [9] 0 0
Bobigny Cedex
Country [10] 0 0
France
State/province [10] 0 0
Montpellier cedex 5
Country [11] 0 0
France
State/province [11] 0 0
Nantes
Country [12] 0 0
France
State/province [12] 0 0
Paris Cedex 4
Country [13] 0 0
France
State/province [13] 0 0
Toulouse cedex 9
Country [14] 0 0
Germany
State/province [14] 0 0
Nordrhein-Westfalen
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Leipzig
Country [17] 0 0
Italy
State/province [17] 0 0
RM
Country [18] 0 0
Italy
State/province [18] 0 0
UD
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Korea
Country [20] 0 0
Peru
State/province [20] 0 0
Lima
Country [21] 0 0
Spain
State/province [21] 0 0
Catalunya
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Switzerland
State/province [23] 0 0
Bern
Country [24] 0 0
Switzerland
State/province [24] 0 0
Zürich
Country [25] 0 0
Turkey
State/province [25] 0 0
Ankara
Country [26] 0 0
Turkey
State/province [26] 0 0
Balcova / Izmir
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Scotland
Country [28] 0 0
United Kingdom
State/province [28] 0 0
West Yorkshire
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Liverpool
Country [30] 0 0
United Kingdom
State/province [30] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00880269