A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00282399
First received: January 25, 2006
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: Subcutaneous Decitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: October 2006
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Phase I: The purpose of this study is 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Additional Information:
No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00282399     History of Changes
Other Study ID Numbers: DACO-019
Study First Received: January 25, 2006
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014