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Phase I Trial of Vorinostat (MK0683, SAHA) in Combination With Decitabine in Patients With AML or MDS
This study is ongoing, but not recruiting participants.
Sponsored by: 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. Patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) are eligible.


Condition Intervention Phase
Leukemia, Myelocytic
Myelodysplastic Syndromes
Drug: vorinostat
Drug: decitabine
Phase I

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Suberoylanilide hydroxamic acid 5-Aza-2'-deoxycytidine
U.S. FDA Resources
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

Further study details as provided by Merck:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of this treatment combination. [ Time Frame: Up to 24 months of treatment. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the efficacy of this combination [ Time Frame: Up to 24 months of treatment. ] [ Designated as safety issue: No ]

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
1
vorinostat, decitabine
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is at least 18 years old
  • Patient has an established diagnosis of one of the following:

    1. Intermediate-high risk MDS
    2. Refractory or relapsed AML
    3. Untreated AML (if patient is not a candidate for standard cytotoxic chemotherapy)
  • Patient is at least 4 weeks from prior treatment and has recovered from all prior treatment side effects
  • Patient has no known liver or kidney problems
  • Patient knows of no reason they can not receive transfusions of blood clotting cells (platelets)
  • Patient is able to swallow capsules
  • Patients both male and female are willing to practice birth control during the study

Exclusion Criteria:

  • Patient has received prior treatment with valproic acid, decitabine or azacitidine
  • Being is less than 18 years of age or if patient has untreated AML is below 60 years of age
  • Patient is a female who is pregnant or breastfeeding
  • Patient has an active infection that requires antibiotics
  • Patient has uncontrolled illness including but not limited to the following: heart problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia), inflammation of the pancreas
  • Patient has a mental or social condition that may interfere with patient following study procedures
  • Patient has known HIV infection or HIV-related malignancy
  • Patient has a known history of hepatitis B or C infection
  • Patient has a known allergy or hypersensitivity to any component of vorinostat or decitabine
  • Patient currently has another active cancer other than certain types of skin cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479232

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

(MedWatch - FDA maintained medical product safety Information)  This link exits the ClinicalTrials.gov site
(PhRMA Clinical Study Results Database - web-based repository for clinical study results)  This link exits the ClinicalTrials.gov site
(Merck: Patient & Caregiver U.S. Product Web Site)  This link exits the ClinicalTrials.gov site

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

Keywords provided by Merck:
Leukemia
Myelocytic
Acute Myelodysplastic Syndromes

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009