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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00451035 |
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: | 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 Chronic Phase Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors |
Estimated Enrollment: | 120 |
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
Belgium | |
Leuven, Belgium | |
Bruxelles, Belgium | |
Godinne, Belgium | |
Germany | |
Mainz, Germany | |
Cologne, Germany | |
Munich, Germany | |
Hamburg, Germany | |
Mannheim, Germany | |
Leipzig, Germany | |
Dusseldorf, Germany |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CLBH589B2202 |
Study First Received: | March 20, 2007 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00451035 |
Health Authority: | Argentina: National Administration of Drugs, Foods, and Medical Technology; Australia: Therapeutic Goods Administration; Belgium: Pharmaceutical Inspectorate; Canada: Health Products and Food Branch; Denmark: 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; The Netherlands: Medicines Evaluation Board; United States: Food and Drug Administration |
Refractory Chronic Myeloid Leukemia in Chronic Phase adults oral LBH589 |
Leukemia Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type |