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A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
This study is currently recruiting participants.
Verified by Eisai Medical Research Inc., November 2008
Sponsored by: Eisai Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00619099
  Purpose

The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: Decitabine
Phase II

Drug Information available for: 5-Aza-2'-deoxycytidine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Open-Label Phase 2 Study of Low Dose Dacogen® for Injection (Decitabine) in Patients With Low or Intermediate 1 Risk Myelodysplastic Syndromes

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • The overall improvement rate (Complete Remission (CR) + Partial Remission (PR) + Marrow CR + Hematologic Improvement (HI)) [ Time Frame: Up to one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Decitabine

Schedule A: Decitabine will be administered Subcutaneous (SQ) daily for 3 consecutive days (Day 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.

Schedule B: Decitabine will be administered SQ every 7 days for 21 days (Day 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.


Detailed Description:

This is a randomized open-label Phase 2 efficacy and safety study of two (2) subcutaneous (SQ) dosing schedules of decitabine in subjects with Low or Intermediate 1 risk MDS. In Schedule A, decitabine will be dosed SQ at 20 mg/m^2/day for 3 consecutive days (1 to 3) every 28 days. In Schedule B, decitabine will be dosed SQ at 20 mg/m^2/day 1 time every 7 days for 21 days (Day 1, 8, and 15) followed by 7 days without an administration of decitabine. This study will be conducted in up to 6 study centers in the United States.

The primary efficacy outcome is the overall improvement rate (Complete Remission [CR] + Partial Remission [PR] + Marrow CR + Hematologic Improvement [HI]).

These two doses will be administered subcutaneously and are lower than the dose currently approved.

The probability that one schedule is superior to the other will be estimated, and the level of toxicity for each schedule will also be evaluated.

  Eligibility

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

Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study:

  1. Male or female patients age 18 years and older.
  2. Patients must sign an institutional review board (IRB)-approved informed consent form, and understand the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
  3. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  4. Adequate renal and hepatic function (creatinine < 2 times upper limit of normal, total bilirubin of < 2 times upper limit of normal, and AST and ALT ≤ 2 times upper limit of normal) unless proven to be related to disease infiltration.
  5. Female patients need a negative serum or urine pregnancy test within 7 days prior to study drug administration (applies only if patient is of childbearing potential. Non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized).
  6. Women of childbearing potential and men must use contraception. Men and women must continue birth control for the duration of the study.
  7. Patients with low or intermediate-1 risk MDS by the International Prognostic Scoring System (IPSS) classification.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

  1. Women who are pregnant or nursing.
  2. Those who have received prior therapy with decitabine.
  3. Prior therapy with azacitidine (Vidaza®).
  4. Those who received growth factor support or lenalidomide in the 30 days prior to the first dose of decitabine.
  5. Those who have received an investigational agent 30 days prior to the first dose of decitabine.
  6. Patients with active, uncontrolled, systemic infection considered opportunistic, life threatening or clinically significant; or any severe, concurrent disease, which, in the judgment of the Investigator and after discussion with the Sponsor and Primary Investigator, would make the patient inappropriate for study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619099

Contacts
Contact: Eisai Medical Services 1-888-422-4743

Locations
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith     330-492-3345 ext 208     csmith@gabrailcancercenter.com    
Principal Investigator: Nashat Gabrail, MD            
United States, Rhode Island
Landmark Medical Center Recruiting
Woonsocket, Rhode Island, United States, 02895
Contact: Lisa Furtado     401-769-4100 ext 2590     lfurtado@landmarkmedical.org    
Principal Investigator: Ahmed Nadeem, MD            
United States, Tennessee
Sarah Cannon Research Recruiting
Nashville, Tennessee, United States, 37203
Contact: Meredith Zimlich     615-329-7245     Meredith.Zimlich@scresearch.net    
Principal Investigator: Daniel Couriel, MD            
United States, Texas
M. D. Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Guillermo Garcia-Manero, MD     713-745-3428     ggarciam@mdanderson.org    
Sponsors and Collaborators
Eisai Inc.
  More Information

Responsible Party: Eisai Inc. ( Eisai Medical Services )
Study ID Numbers: DACO-026
Study First Received: February 8, 2008
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00619099  
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:
Myelodysplastic Syndrome
Decitabine
Dacogen
MGI PHARMA, Inc.

Study placed in the following topic categories:
Myelodysplastic syndromes
Preleukemia
Precancerous Conditions
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Decitabine
Bone Marrow Diseases

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Syndrome
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009