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Completed

NCT Number: NCT00621244

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies

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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Key information

Conditions

Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site, Parkville, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBH589

Drug

Primary outcomes

  1. Number of Participants DLT in Arm 1 in Dose Escalation Phase

    Time frame: Cycle 1 (28-day treatment cycle)

    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.

  2. Number of Participants DLT in Arm 2 in Dose Escalation Phase

    Time frame: Cycle 1 (28-day treamtent cycle)

    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.

Secondary outcomes

  1. Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)

    Time frame: 3.5 years

    Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.

  2. Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase

    Time frame: 1.2 years

    Stage 2 did not open for enrollment.

  3. Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)

    Time frame: 3.5 years

    Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.

  4. Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)

    Time frame: 3.5 years

    Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.

  5. Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2

    Time frame: Day 1

  6. Half Life of Panobinostat After the First Dose in Arms 1 and 2

    Time frame: Day 1

  7. Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15

    Time frame: Day 15

    From day 15 by dose with schedule: MWF every week

  8. Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15

    Time frame: Day 15

  9. Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1

    Time frame: Day 15/day 1

    MWF Every week schedule n = number of subjects with non-missing values.

  10. 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

    Reporting the number of patients with a reading at the timepoint in the dose group.

  11. 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)

  12. 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)

  13. Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y

    Time frame: Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)

  14. Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)

    Time frame: Post dose to pre-dose (up to 3.5 years)

    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]))

  15. Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)

    Time frame: Post dose to pre-dose (up to 3.5 years)

    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]))

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Feb 22, 2008
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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