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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00449761 |
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myeloid, Chronic |
Drug: LBH589 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicentre Study of Oral LBH589 in Patients With Accelerated Phase or Blast Phase (Blast Crisis) Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors |
Estimated Enrollment: | 71 |
Study Start Date: | January 2007 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CLBH589B2211 |
Study First Received: | March 20, 2007 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00449761 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Pharmaceutical Inspectorate; Canada: Health Products and Food Branch; Denmark: Danish Medicines Agency; Europe : European agency for the evaluation of medicinal products (EMEA); Finland: National Agency for Medicines; France: Sanitary Safety of Health Products Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Poland: Drug Institute; Russia: Ministry of Public Health; South Africa: Department of Health; Spain: Spanish Drug Agency; Netherlands: Medicines Evaluation Board (MEB); United States: Food and Drug Administration |
Refractory Chronic Myeloid Leukemia accelerated phase |
blast phase (blast crisis) adults oral LBH589 |
Blast Crisis Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type Cell Transformation, Neoplastic |