Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00490776

Purpose

This study will evaluate the safety and efficacy of LBH589B in adult patients with refractory/resistant Cutaneous T-Cell Lymphoma and prior HDAC inhibitor therapy.

Condition	Intervention	Phase
Cutaneous T-Cell Lymphoma	Drug: LBH589	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma Skin Conditions

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To determine the overall response rate of patients treated with LBH589 by using the modified Severity-Weighted Assessment Tool to assess skin disease and the evaluation of disease in the viscera, lymph nodes, and blood (circulation SS cells) [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the response rate using the Physicians Global Assessment of Clinical Condition(PGA)of patients with resistant CTCL [ Time Frame: Monthly ] [ Designated as safety issue: No ]
To determine the response rate using Modified Severity Weighted Assessment (mSWAT) skin score of patients with resistant CTCL [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Responses in index lesions by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Overall response rate of patients with resistant CTCL treated with oral LBH589 by using the modified Physician's Global Assessment (PGA) to assess skin disease and the evaluation of disease in the viscera, lymph nodes and blood (circulating SS cells). [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	June 2007
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LBH589	Drug: LBH589 Other Name: panobinostat

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Written informed consent obtained prior to any screening procedures
Age greater than or equal to 18 years old
Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible. Patients with transformed CTCL are eligible.
Patients must have been treated with an HDAC inhibitor given for the treatment of CTCL. Patients must have had disease progression on or following treatment with an HDAC inhibitor. Patients are also eligible if they had an inadequate response to an HDAC inhibitor defined as stable disease as the best response after at least 3 months of therapy. Patients previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.

Exclusion criteria:

Patients with a history of visceral disease including CNS involvement (i.e. stage IVB CTCL). Note, patients who have SS with bone marrow involvement are eligible.
Impaired cardiac function
Concomitant use of drugs with a risk of causing torsades de pointes
Patients who have received chemotherapy or any investigational drug or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Less than 3 months since prior electron beam therapy
Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study and 3 months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490776

Locations

United States, Alabama
University of Alabama at Birmingham/ The Kirklin Clinic
Birmingham, Alabama, United States, 35233
United States, California
UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Health Sciences Center/Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80010
United States, Florida
Florida Academic Dermatology Centers
Miami, Florida, United States, 33136
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Rush Presbyterian Hospital/St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Missouri
St. Louis University Cancer Cennter
St. Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Our Lady of Mercy Medical Center/Comprehensive Cancer Center
Bronx, New York, United States, 10466
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
NYU Clinical Cancer Center
New York, New York, United States, 10016
United States, North Carolina
Wake University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
University of Oklahoma-Tulsa
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Craig Okada
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburg Medical Center
Pittsburg, Pennsylvania, United States, 15213
United States, Tennessee
The Jones Clinic
Germantown, Tennessee, United States, 38138
United States, Texas
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-102

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00490776 History of Changes
Other Study ID Numbers:	CLBH589B2212
Study First Received:	June 21, 2007
Last Updated:	April 27, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Cutaneous T-Cell Lymphoma
adults
Mycosis Fungoides
Sézary Syndrome
CTCL

Additional relevant MeSH terms:

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 22, 2012