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Sponsors and Collaborators: |
Novartis no collaborators |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00699296 |
This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma. LBH589 is administered orally once a day for three days per week.
Condition | Intervention | Phase |
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Cutaneous T-Cell Lymphoma Leukemia-Lymphoma, Adult T-Cell |
Drug: Panobinostat (LBH589) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Oral LBH589 in Patients With Cutaneous T-Cell Lymphoma and Adult T-Cell Leukemia/Lymphoma |
Estimated Enrollment: | 35 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Panobinostat (LBH589)
20mg/day p.o. on three times-a- week
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contact: Novartis Pharma KK | +81-3-3498-6393 |
Japan | |
The University of Tokyo Hospital | Recruiting |
Tokyo, Japan | |
Contact +81-3-3498-6393 | |
Okayama University Hospital | Recruiting |
Okayama, Japan | |
Contact +81-3-3498-6393 | |
University Hospital of Occupational and Environmental Health | Recruiting |
Fukuoka, Japan | |
Contact +81-3-3498-6393 | |
Imamura Bun-in Hospital | Recruiting |
Kagoshima, Japan | |
Contact +81-3-3498-6393 | |
Kumamoto University Hospital | Recruiting |
Kumamoto, Japan | |
Contact +81-3-3498-6393 | |
University of Miyazaki Hospital | Recruiting |
Miyazaki, Japan | |
Contact +81-3-3498-6393 | |
Nagasaki University Hospital of Medicine and Dentistry | Recruiting |
Nagasaki, Japan | |
Contact +81-3-3498-6393 |
Principal Investigator: | Makoto Sugaya | The University of Tokyo Hospital |
Principal Investigator: | Kenji Iwatsuki | Okayama University |
Principal Investigator: | Yoshiki Tokura | University Hospital of Occupational and Environmental Health |
Principal Investigator: | Kunihiro Tsukasaki | Nagasaki University Hospital of Medicine and Dentistry |
Principal Investigator: | Hironobu In | Kumamoto University Hospital |
Principal Investigator: | Mitsuru Setoyama | University of Miyazaki Hospital |
Principal Investigator: | Atae Utsunomiya | Imamura Bun-in Hospital |
Responsible Party: | Novartis Pharma K.K.: Japan ( External Affairs ) |
Study ID Numbers: | CLBH589B1201 |
Study First Received: | June 13, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00699296 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
LBH589 HDAC inhibitor cutaneous T-ceII lymphoma adult T-cell leukemia |
Sezary syndrome Leukemia, Lymphoid Immunoproliferative Disorders Cutaneous T-cell lymphoma Leukemia-Lymphoma, Adult T-Cell Sezary Syndrome Mycosis Fungoides Leukemia |
Mycoses Lymphatic Diseases Lymphoma, T-Cell Leukemia, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |