A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00621244

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma

Drug Information available for: LBH589

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	308
Study Start Date:	March 2006
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: LBH589
2: Experimental	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

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
Mainz, Germany
Novartis Investigative Site
Frankfurt, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLBH589B2102
Study First Received:	February 12, 2008
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00621244 History of Changes
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

Study placed in the following topic categories:

Immunoproliferative Disorders
Hematologic Neoplasms
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Multiple Myeloma
Leukemia
Lymphatic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Hematologic Neoplasms
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma

Leukemia
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 04, 2009