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A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00282399
Recruitment Status : Terminated
First Posted : January 26, 2006
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Subcutaneous Decitabine Phase 1

Detailed Description:

Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS

Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.

Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
Study Start Date : October 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: DACO-019 2mg/m^2
DACO-019 2mg/m^2 twice daily (BID)
Drug: Subcutaneous Decitabine
Experimental: DACO-019 5mg/m^2
DACO-019 5mg/m^2 BID
Drug: Subcutaneous Decitabine
Experimental: DACO-019 10mg/m^2
DACO-019 10mg/m^2 BID
Drug: Subcutaneous Decitabine



Primary Outcome Measures :
  1. Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS. [ Time Frame: Up to 8 cycles (224 days) ]
  2. Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study. [ Time Frame: Up to 12 cycles (336 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  2. Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

  1. Prior therapy with decitabine or azacytidine (Vidaza).
  2. Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
  3. Clinically significant anemia.
  4. Prior history of malignancy other than MDS.
  5. Any active infection.
  6. Radiotherapy within 14 days prior to study enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282399


Locations
United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Florida
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Eisai Inc.

Additional Information:
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00282399     History of Changes
Other Study ID Numbers: DACO-019
First Posted: January 26, 2006    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Eisai Inc.:
Myelodysplastic Syndrome
MGI Pharma
Decitabine
Dacogen

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Decitabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors