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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00479232 |
This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine. Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) are eligible.
Condition | Intervention | Phase |
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Leukemia, Myelocytic Myelodysplastic Syndromes |
Drug: vorinostat Drug: decitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Clinical Trial of Vorinostat in Combination With Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome |
Estimated Enrollment: | 80 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
vorinostat, decitabine
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Drug: vorinostat
vorinostat 400 mg capsules once daily given 7-14 days in 28 day cycles. Up to 24 months of treatment.
Drug: decitabine
decitabine IV 20 mg/m2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has an established diagnosis of one of the following:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_500, MK0683-055 |
Study First Received: | May 24, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00479232 |
Health Authority: | United States: Food and Drug Administration |
Leukemia Myelocytic Acute Myelodysplastic Syndromes |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Vorinostat Acute myelogenous leukemia |
Decitabine Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia Preleukemia Bone Marrow Diseases Acute myelocytic leukemia |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Neoplasms by Histologic Type Disease Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions |
Neoplasms Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |