TriangleNCT00621244 · REGISTRY CONDITION SEARCH
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE1, PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2021-01-05
This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants DLT in Arm 1 in Dose Escalation Phase
Number of Participants DLT in Arm 2 in Dose Escalation Phase
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
Half Life of Panobinostat After the First Dose in Arms 1 and 2
Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility 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 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: LBH589
- label
- Arm 1, Group X
- type
- EXPERIMENTAL
- intervention Names
- Drug: LBH589
- label
- Arm 1, Group Y
- type
- EXPERIMENTAL
- intervention Names
- Drug: LBH589
- label
- Arm 2, Group X
- type
- EXPERIMENTAL
- description
- 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.
- intervention Names
- Drug: LBH589
- label
- Arm 2, Group Y
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm 1, Group X
- Arm 1, Group Y
- Arm 2, Group X
- Arm 2, Group Y
- name
- LBH589
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 175
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Number of Participants DLT in Arm 1 in Dose Escalation Phase
- time Frame
- Cycle 1 (28-day treatment cycle)
- description
- 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.
- measure
- Number of Participants DLT in Arm 2 in Dose Escalation Phase
- time Frame
- Cycle 1 (28-day treamtent cycle)
- secondary Outcomes
- description
- Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
- measure
- Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
- time Frame
- 3.5 years
- description
- Stage 2 did not open for enrollment.
- measure
- Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
- time Frame
- 1.2 years
- description
- Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.
- measure
- Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
- time Frame
- 3.5 years
- description
- Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
- measure
- Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
- time Frame
- 3.5 years
- measure
- Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
- time Frame
- Day 1
- measure
- Half Life of Panobinostat After the First Dose in Arms 1 and 2
- time Frame
- Day 1
- description
- From day 15 by dose with schedule: MWF every week
- measure
- Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
- time Frame
- Day 15
- measure
- Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
- time Frame
- Day 15
- description
- MWF Every week schedule n = number of subjects with non-missing values.
- measure
- Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
- time Frame
- Day 15/day 1
- description
- Reporting the number of patients with a reading at the timepoint in the dose group.
- measure
- Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
- time Frame
- Days 1, 5, 8, 10, 15
- measure
- Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
- time Frame
- Days 5, 8, end of study (up to 3.5 years)
- measure
- Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
- time Frame
- Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)
Full study description
- 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
Source references
- see Also Links
- label
- Results for CLBH589B2102 can be found on the Novartis Clinical Trial Results Website
Source notices and limitations
Discovery and provenance
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- source file
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Preserved source evidence · Not medical advice