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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Myeloma; Lymphoma; Leukemia

Treatments: Drug: LBH589

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621244

CLBH589B2102

2005-003670-26

Details and patient eligibility

About

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

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 4 patient groups

Arm 1, Group X

Experimental group

Treatment:

Drug: LBH589

Arm 1, Group Y

Experimental group

Treatment:

Drug: LBH589

Arm 2, Group X

Experimental group

Treatment:

Drug: LBH589

Arm 2, Group Y

Experimental group

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.

Treatment:

Drug: LBH589