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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis Pharmaceuticals |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00939159 |
Primary Objective:
To determine the clinical efficacy, safety, and tolerability of 20 mg oral LBH589 three times a week for three weeks out of a four week cycle in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS)
Secondary Objective:
To determine the molecular effects of LBH589 administration in this patient population.
Condition | Intervention | Phase |
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Myelodysplastic Syndrome |
Drug: LBH589 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome |
Estimated Enrollment: | 40 |
Study Start Date: | August 2009 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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LBH589: Experimental |
Drug: LBH589
20 mg capsules by mouth 3 times a week for 3 weeks in a 28-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:
Patients with intermediate-1 risk MDS or transfusion dependent low risk MDS by the IPSS classification.
Patient must have one or more cytopenia as defined by IPSS (Cytopenias are defined as an absolute neutrophil count < 1800 K/uL; or hemoglobin < 10 g/dl or platelets < 10^5 K/uL).
Exclusion Criteria:
Contact: Guillermo Garcia-Manero, MD | 713-745-3428 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Guillermo Garcia-Manero, MD |
Study Chair: | Guillermo Garcia-Manero, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Guillermo Garcia-Manero, MD / Professor ) |
Study ID Numbers: | 2007-0713 |
Study First Received: | July 10, 2009 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00939159 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Low or Intermediate-1 Risk Myelodysplastic Syndrome MDS Cancer LBH589 |
Preleukemia Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Bone Marrow Diseases |
Neoplasms Preleukemia Pathologic Processes Disease Precancerous Conditions |
Hematologic Diseases Syndrome Myelodysplastic Syndromes Bone Marrow Diseases |