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

Novartis Pharmaceuticals175 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

Lymphoma Leukemia Multiple Myeloma

Interventions

LBH589DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia

Augusta, Georgia, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

MD Anderson Cancer Center/University of Texas

Houston, Texas, United States

Novartis Investigative Site

Parkville, Victoria, Australia

Outcomes

Primary Outcomes

Number of Participants DLT in Arm 1 in Dose Escalation Phase

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.

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

Number of Participants DLT in Arm 2 in Dose Escalation Phase

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.

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

Secondary Outcomes

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

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

Time frame: 3.5 years

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

Stage 2 did not open for enrollment.

Time frame: 1.2 years

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

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

Time frame: 3.5 years

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

Data from ClinicalTrials.gov

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