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

NCT00621244 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CLBH589B21022005-003670-26
• Study Type: interventional
• Target: 175
• Locations: 3 countries
• Sites: 7

Brief Summary

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

Conditions

Lymphoma; Leukemia; Multiple Myeloma

Keywords

HDAC inhibitor; Oral; LBH589; Lymphoma; Leukemia; Multiple myeloma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Cycle 1 (28-day treamtent cycle)

Secondary Outcomes (15)

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

  3.5 years

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

  1.2 years

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

  3.5 years

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

  3.5 years

• Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2

  Day 1

Study Arms (4)

Arm 1, Group X

EXPERIMENTAL

Drug: LBH589

Arm 1, Group Y

EXPERIMENTAL

Drug: LBH589

Arm 2, Group X

EXPERIMENTAL

Drug: LBH589

Arm 2, Group Y

EXPERIMENTAL

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.

Drug: LBH589

Interventions

LBH589 DRUG

Arm 1, Group X; Arm 1, Group Y; Arm 2, Group X; Arm 2, Group Y

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia

Augusta, Georgia, 30912, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MD Anderson Cancer Center/University of Texas

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Parkville, Victoria, 3002, Australia

Location

Novartis Investigative Site

Prahran, Victoria, 3181, Australia

Location

Novartis Investigative Site

Frankfurt/M, 60590, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Related Links

• Results for CLBH589B2102 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Lymphoma; Leukemia; Multiple Myeloma

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2003
• Primary Completion: December 3, 2009
• Study Completion: December 3, 2009
• Last Updated: January 5, 2021
• Results First Posted: August 17, 2017

Record last verified: 2017-07

Locations

AU (2); DE (2); US (3)