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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The overall improvement rate
Up to one year
United States: Food and Drug Administration
|Gabrail Cancer Center||Canton, Ohio 44718|
|Sarah Cannon Research||Memphis, Tennessee 38120|
|M. D. Anderson||Houston, Texas|
|Landmark Medical Center||Woonsocket, Rhode Island 02895|