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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00479232 |
Purpose
This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine as well as the in vivo molecular and biological effects of vorinostat in patients with refractory or relapsed AML and intermediate or high risk IPSS MDS. Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) are eligible.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Myelodysplastic Syndromes |
Drug: Comparator: vorinostat (sequential) Drug: Comparator: decitabine Drug: Comparator: vorinostat (concurrent) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety 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: | 71 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Cohort 1
|
Drug: Comparator: vorinostat (sequential)
vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles. Up to 24 months of treatment.
Drug: Comparator: 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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2: Experimental
Cohort 2
|
Drug: Comparator: decitabine
decitabine IV 20 mg/m2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
Drug: Comparator: vorinostat (concurrent)
vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient is at least 18 years old with refractory/relapsed AML
Exclusion Criteria:
Contacts and Locations
More Information
| 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: | December 8, 2009 |
| 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 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 |