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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00425555




Registration number
NCT00425555
Ethics application status
Date submitted
22/01/2007
Date registered
23/01/2007
Date last updated
20/08/2021

Titles & IDs
Public title
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Scientific title
A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Secondary ID [1] 0 0
2006-000880-27
Secondary ID [2] 0 0
CLBH589B2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous T-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Previously treated with oral bexarotene - Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).

Experimental: No prior oral bexarotene treatment - Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
Assessment method [1] 0 0
Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as: * Complete Response (CR): no evidence of skin disease * Partial Response (PR): = 50% decrease of the modified SWAT score compared with baseline * Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score * Progressive Disease (PD): = 25% increase in the modified SWAT score compared with baseline.
Timepoint [1] 0 0
Baseline up to 6 Months of Follow up
Secondary outcome [1] 0 0
The Overall Response Rate Using mSWAT Skin Score
Assessment method [1] 0 0
Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed.
Timepoint [1] 0 0
Baseline up to Cycle 12, an average of 12 months
Secondary outcome [2] 0 0
Time to Response for Responders
Assessment method [2] 0 0
Time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
Timepoint [2] 0 0
Baseline up to Cycle 12, an average of 12 months
Secondary outcome [3] 0 0
Duration of Response (DOS)
Assessment method [3] 0 0
Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
Timepoint [3] 0 0
Baseline up to Cycle 12, an average of 12 months
Secondary outcome [4] 0 0
Progression-free Survival (PFS)
Assessment method [4] 0 0
PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment
Timepoint [4] 0 0
Baseline up to Cycle 12, an average of 12 months
Secondary outcome [5] 0 0
Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12
Assessment method [5] 0 0
Skin index measurement (Skindex-29) was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess emotions scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Timepoint [5] 0 0
Baseline up to Cycle 12, an average of 12 months
Secondary outcome [6] 0 0
Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12
Assessment method [6] 0 0
Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess functioning scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Timepoint [6] 0 0
Baseline up to Cycle 12, an average of 12 months
Secondary outcome [7] 0 0
Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12
Assessment method [7] 0 0
Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess physical symptoms scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Timepoint [7] 0 0
Baseline up to Cycle 12, an average of 12 months
Secondary outcome [8] 0 0
Maximum Plasma Concentration (Cmax) of Panobinostat
Assessment method [8] 0 0
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
Timepoint [8] 0 0
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Secondary outcome [9] 0 0
Time to Peak Concentration (Tmax) of Panobinostat
Assessment method [9] 0 0
Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's PK profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
Timepoint [9] 0 0
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Secondary outcome [10] 0 0
Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat
Assessment method [10] 0 0
AUC is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours. The area under the plasma concentration-time curve from time zero to 48 hours. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
Timepoint [10] 0 0
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Secondary outcome [11] 0 0
Time of Clast (Tlast) of Panobinostat
Assessment method [11] 0 0
Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.
Timepoint [11] 0 0
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
Secondary outcome [12] 0 0
Last Observed Plasma Concentration (Clast) of Panobinostat
Assessment method [12] 0 0
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
Timepoint [12] 0 0
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Written informed consent obtained prior to any screening procedures
2. Age = 18 years old
3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen.
6. Patients will be accrued to one of two groups: Patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Prior treatment with an HDAC inhibitor.
2. Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
3. Impaired cardiac function
4. Concomitant use of drugs with a risk of causing torsades de pointes
5. Patients who have received chemotherapy or any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
6. Less than 3 months since prior electron beam therapy
7. Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control, and male patients whose sexual partners are women of childbearing potential not using effective birth control
8. Uncontrolled hypertension
9. Concomitant use of any anti-cancer therapy or radiation therapy. Low potency topical steroid use is permitted. Topical bexarotene use is prohibited during the trial
10. Concomitant use of CYP3A4/5 inhibitors.
11. Patients with unresolved diarrhea > CTCAE grade 1
12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
13. Other concurrent severe and/or uncontrolled medical conditions
14. Patients who would need to receive valproic acid for any reason during the study or = 5 days prior to starting study drug.

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
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Belgium
State/province [17] 0 0
Yvoir
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Finland
State/province [20] 0 0
Helsinki
Country [21] 0 0
France
State/province [21] 0 0
Cedex 02
Country [22] 0 0
France
State/province [22] 0 0
Creteil
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Minden
Country [26] 0 0
Germany
State/province [26] 0 0
Würzburg
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Italy
State/province [28] 0 0
AN
Country [29] 0 0
Italy
State/province [29] 0 0
BO
Country [30] 0 0
Italy
State/province [30] 0 0
FI
Country [31] 0 0
Italy
State/province [31] 0 0
TO
Country [32] 0 0
Italy
State/province [32] 0 0
Napoli
Country [33] 0 0
Spain
State/province [33] 0 0
Catalunya
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Switzerland
State/province [35] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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

TypeCitations or Other Details
Journal Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz R... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00425555