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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00451035 |
Purpose
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia in Chronic Phase |
Drug: LBH589 |
Phase II Phase III |
| 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, Multicentre Study of Oral LBH589 in Patients With Chronic Phase Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors |
| Enrollment: | 29 |
| Study Start Date: | January 2007 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: LBH589
Other Name: panobinostat
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| Belgium | |
| Novartis Investigative Site | |
| Bruxelles, Belgium | |
| Novartis Investigative Site | |
| Godinne, Belgium | |
| Novartis Investigative Site | |
| Leuven, Belgium | |
| Germany | |
| Novartis Investigative Site | |
| Cologne, Germany | |
| Novartis Investigative Site | |
| Dusseldorf, Germany | |
| Novartis Investigative Site | |
| Hamburg, Germany | |
| Novartis Investigative Site | |
| Leipzig, Germany | |
| Novartis Investigative Site | |
| Mainz, Germany | |
| Novartis Investigative Site | |
| Mannheim, Germany | |
| Novartis Investigative Site | |
| Munich, Germany | |
| Study Director: | Novartis Pharmaceuticlas | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00451035 History of Changes |
| Other Study ID Numbers: | CLBH589B2202 |
| Study First Received: | March 20, 2007 |
| Last Updated: | November 18, 2009 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; Denmark: Danish Medicines Agency; European Union: European Medicines Agency; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; South Africa: Department of Health; Spain: Spanish Agency of Medicines; Netherlands: Medicines Evaluation Board (MEB); United States: Food and Drug Administration |
|
Refractory Chronic Myeloid Leukemia in Chronic Phase adults oral LBH589 |
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |