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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia Myelocytic Acute Myelodysplastic Syndromes |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Vorinostat Leukemia, Myeloid Decitabine Leukemia, Myeloid, Acute |
Leukemia Preleukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Bone Marrow Diseases |
Anticarcinogenic Agents Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Sensory System Agents Syndrome Therapeutic Uses |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Vorinostat Enzyme Inhibitors Leukemia, Myeloid Decitabine Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents |