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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00742027 |
This study will evaluate the efficacy of oral panobinostat in patients with refractory/relapsed classical HL who have received prior treatment with autologous bone marrow transplant and other commonly used chemotherapies such as gemcitabine, vinorelbine, or vinblastine. Safety of panobinostat will also be assessed. Other markers that may correlate with efficacy or safety will be explored.
Condition | Intervention | Phase |
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Hodgkin's Lymphoma |
Drug: Panobinostat |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma After Failure of High-Dose Chemotherapy With Autologous Stem Cell Transfusion and a Gemcitabine- or Vinorelbine- or Vinblastine-Containing Treatment Regimen |
Estimated Enrollment: | 102 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Panobinostat
Oral 40 mg/dose, three times per week, every week dosing on a 21-day cycle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values must be in range, more specifically:
Exclusion Criteria:
Contact: Novartis US | 800 340 6843 | |
Contact: Novartis Basel | 41 61 324 1111 |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CLBH589E2214 |
Study First Received: | August 25, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00742027 |
Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Ministry of Social Affairs, Public Health and the Environment; Brazil: Ministry of Health; Egypt: Central Administration of Pharmaceutical Affairs; France: Afssaps - French Health Products Safety Agency; Germany: Ministry of Health; Israel: Ministry of Health; Italy: Agenzia Italiana del Farmaco (AIFA); Malaysia: Department of public health, DCA (Drug Control Agency); New Zealand: Medsafe; Singapore: Health Sciences Authority; Spain: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Classical Hodgkin Lymphoma Classical Hodgkin's Lymphoma Hodgkin Lymphoma Hodgkin's Lymphoma Nodular sclerosing Mixed-cellularity Lymphocyte-rich |
Lymphocyte depleted HL Classical HL Refractory Hodgkin's Lymphoma Refractory Hodgkin Lymphoma Refractory HL |
Lymphatic Diseases Vinorelbine Hodgkin's disease Immunoproliferative Disorders Hodgkin lymphoma, adult |
Vinblastine Gemcitabine Lymphoproliferative Disorders Hodgkin Disease Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |