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Randomized Open-label Phase 2 Study of Low Dose Dacogen® for Injection (Decitabine) in Patients With Low or Intermediate 1 Risk Myelodysplastic Syndromes

Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndrome

Thank you

Trial Information

Randomized Open-label Phase 2 Study of Low Dose Dacogen® for Injection (Decitabine) in Patients With Low or Intermediate 1 Risk Myelodysplastic Syndromes

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. This
study will be conducted in up to 6 study centers in the United States.

The primary efficacy outcome is the overall improvement rate. These two doses will be
administered subcutaneously. 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.

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The overall improvement rate

Outcome Time Frame:

Up to one year

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • Decitabine
  • Dacogen
  • MGI PHARMA, Inc.
  • Myelodysplastic Syndromes
  • Preleukemia



Gabrail Cancer Center Canton, Ohio  44718
Sarah Cannon Research Memphis, Tennessee  38120
M. D. Anderson Houston, Texas  
Landmark Medical Center Woonsocket, Rhode Island  02895