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| Sponsor: | Merck |
|---|---|
| Information provided by (Responsible Party): | 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 Acute Myelogenous Leukemia (AML) and intermediate or high risk as defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS). Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome 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: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Clinical Trial of Vorinostat in Combination With Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome |
| Enrollment: | 71 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
|
Experimental: 2
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 |
| ClinicalTrials.gov Identifier: | NCT00479232 History of Changes |
| Other Study ID Numbers: | MK-0683-055, 2007_500 |
| Study First Received: | May 24, 2007 |
| Results First Received: | April 28, 2011 |
| Last Updated: | October 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Leukemia Myelocytic Acute Myelodysplastic Syndromes |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Decitabine Vorinostat Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Histone Deacetylase Inhibitors |