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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00621244
Registration number
NCT00621244
Ethics application status
Date submitted
12/02/2008
Date registered
22/02/2008
Date last updated
5/01/2021
Titles & IDs
Public title
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
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Scientific title
A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies
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Secondary ID [1]
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2005-003670-26
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Secondary ID [2]
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CLBH589B2102
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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:
Lymphoma
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Leukemia
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Multiple Myeloma
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Arm 1, Group X -
Experimental: Arm 1, Group Y -
Experimental: Arm 2, Group X -
Experimental: Arm 2, Group Y - Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
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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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Number of Participants DLT in Arm 1 in Dose Escalation Phase
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Assessment method [1]
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Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
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Timepoint [1]
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Cycle 1 (28-day treatment cycle)
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Primary outcome [2]
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Number of Participants DLT in Arm 2 in Dose Escalation Phase
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Assessment method [2]
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Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly).
A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
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Timepoint [2]
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Cycle 1 (28-day treamtent cycle)
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Secondary outcome [1]
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Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
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Assessment method [1]
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Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
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Timepoint [1]
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3.5 years
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Secondary outcome [2]
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Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
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Assessment method [2]
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Stage 2 did not open for enrollment.
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Timepoint [2]
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1.2 years
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Secondary outcome [3]
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Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
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Assessment method [3]
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Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.
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Timepoint [3]
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3.5 years
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Secondary outcome [4]
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Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
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Assessment method [4]
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Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
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Timepoint [4]
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3.5 years
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Secondary outcome [5]
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Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
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Assessment method [5]
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Timepoint [5]
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Day 1
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Secondary outcome [6]
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Half Life of Panobinostat After the First Dose in Arms 1 and 2
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Assessment method [6]
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Timepoint [6]
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Day 1
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Secondary outcome [7]
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Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
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Assessment method [7]
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From day 15 by dose with schedule: MWF every week
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Timepoint [7]
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Day 15
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Secondary outcome [8]
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Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
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Assessment method [8]
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Timepoint [8]
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Day 15
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Secondary outcome [9]
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Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
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Assessment method [9]
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MWF Every week schedule n = number of subjects with non-missing values.
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Timepoint [9]
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Day 15/day 1
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Secondary outcome [10]
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Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
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Assessment method [10]
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Reporting the number of patients with a reading at the timepoint in the dose group.
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Timepoint [10]
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Days 1, 5, 8, 10, 15
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Secondary outcome [11]
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Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
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Assessment method [11]
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Timepoint [11]
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Days 5, 8, end of study (up to 3.5 years)
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Secondary outcome [12]
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Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
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Assessment method [12]
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Timepoint [12]
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Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)
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Secondary outcome [13]
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Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
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Assessment method [13]
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Timepoint [13]
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Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)
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Secondary outcome [14]
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Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
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Assessment method [14]
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All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (= 7 days post last dose (preferably = 4 days \[96 hours\]))
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Timepoint [14]
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Post dose to pre-dose (up to 3.5 years)
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Secondary outcome [15]
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Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
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Assessment method [15]
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All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (= 7 days post last dose (preferably = 4 days \[96 hours\]))
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Timepoint [15]
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Post dose to pre-dose (up to 3.5 years)
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Adult patients (=18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
* World Health Organization (WHO) performance status = 2
* Patients who met protocol-specified hematologic and non-hematologic laboratory values
* Patients with adequate liver and renal function
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Minimum age
18
Years
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Maximum age
No limit
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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
Exclusion criteria:
* Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
* Peripheral neuropathy = CTCAE grade 2
* Unresolved diarrhea = CTCAE grade 2
* Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
* Female patients who were pregnant or breast feeding
* Patients who were unwilling to use an effective method of birth control
* Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
* Patients with another primary malignancy that required active intervention or were clinically significant
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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
Single group
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Other design features
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Phase
Phase 1
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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
1/03/2003
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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
3/12/2009
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Sample size
Target
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Accrual to date
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Final
175
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Parkville
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Recruitment hospital [2]
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Novartis Investigative Site - Prahran
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Recruitment postcode(s) [1]
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3002 - Parkville
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Recruitment postcode(s) [2]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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Germany
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State/province [4]
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Frankfurt/M
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Country [5]
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Germany
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State/province [5]
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Mainz
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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 evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
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Trial website
https://clinicaltrials.gov/study/NCT00621244
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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/NCT00621244
Download to PDF