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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00621244
First received: February 12, 2008
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

This study will evaluate safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies


Condition Intervention Phase
Lymphoma
Leukemia
Multiple Myeloma
Drug: LBH589
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Establish the maximum tolerated dose and dose-limiting toxicity for two different dosing schedules (MWF weekly or MWF every other week), [ Time Frame: 2.7 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the safety and tolerability of LBH589 throughout study and up to 28 days after last dose of study drug [ Time Frame: 3.4 years ] [ Designated as safety issue: Yes ]

Enrollment: 308
Study Start Date: March 2006
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: LBH589
Experimental: 2 Drug: LBH589

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adult patients (≥18 years old) with advanced hematological malignancies who have relapsed after or are refractory to standard therapy, or for which no standard therapy exists; or, are considered inappropriate candidates for standard therapy
  • World Health Organization (WHO) performance status ≤ 2
  • Patients must meet protocol-specified hematologic and non-hematologic laboratory values
  • Patients must have 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 may compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that may significantly alter aborption of LBH589
  • Female patients who are pregnant or breast feeding
  • Patients not willing to use an effective method of birth control
  • Patients taking medications specified by the protocol as prohibited for administration in combination with LBH589
  • Patients with another primary malignancy that currently requires active intervention or is currently clinically significant

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621244

Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Australia
Novartis Investigative Site
Melbourne, Australia
Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Mainz, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00621244     History of Changes
Other Study ID Numbers: CLBH589B2102
Study First Received: February 12, 2008
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Australia: Therapeutic Goods Administration

Keywords provided by Novartis:
HDAC inhibitor
Oral
LBH589
Lymphoma
Leukemia
Multiple myeloma

Additional relevant MeSH terms:
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neoplasms by Site
Panobinostat
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014