Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)
NCT ID: NCT00490776
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2007-07-05
2009-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Panobinostat 20 mg
Participants received panobinostat, 20 milligrams (mg), capsules, orally, thrice weekly on alternate Days 1, 3, and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression, and/or physician's discretion to discontinue the treatment.
Panobinostat
Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly.
Interventions
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Panobinostat
Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age greater than or equal to 18 years old
3. Participants with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome (SS). Participants with SS who have bone marrow involvement are also eligible. Participants with transformed CTCL are eligible
4. Participants must have been treated with an HDAC inhibitor given for the treatment of CTCL. Participants must have had disease progression on or following treatment with an HDAC inhibitor. Participants 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. Participants previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.
5. Baseline multiple-gated acquisition scan (MUGA) or echocardiogram must have demonstrated left ventricular ejection fraction (LVEF) ≥ the lower limit of the institutional normal
6. ECOG performance status ≤ 2
Exclusion Criteria
2. Impaired cardiac function
3. Concomitant use of drugs with a risk of causing torsades de pointes
4. Participants 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
5. Less than 3 months since prior electron beam therapy
6. 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Alabama at Birmingham/ The Kirklin Clinic
Birmingham, Alabama, United States
UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology
Los Angeles, California, United States
University of Colorado Health Sciences Center/Anschutz Cancer Pavillion
Aurora, Colorado, United States
Florida Academic Dermatology Centers
Miami, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush Presbyterian Hospital/St. Luke's Medical Center
Chicago, Illinois, United States
St. Louis University Cancer Cennter
St Louis, Missouri, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Clinical Cancer Center
New York, New York, United States
Our Lady of Mercy Medical Center/Comprehensive Cancer Center
The Bronx, New York, United States
Wake University Health Sciences
Winston-Salem, North Carolina, United States
University of Oklahoma-Tulsa
Tulsa, Oklahoma, United States
Craig Okada
Portland, Oregon, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
The Jones Clinic
Germantown, Tennessee, United States
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Other Identifiers
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CLBH589B2212
Identifier Type: -
Identifier Source: org_study_id
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