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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-01

Study Completion Date

2009-12-03

Brief Summary

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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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Detailed Description

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Conditions

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Lymphoma Leukemia Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1, Group X

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

Arm 1, Group Y

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

Arm 2, Group X

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

Arm 2, Group Y

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.

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

Interventions

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LBH589

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No