A Phase I/II Clinical Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome
This is a phase 1/2, open-label (both physician and patient know the name and dosage of
drug), multi-center trial in Myelodysplastic Syndrome (MDS). The purpose of this study is to
assess the safety and efficacy of decitabine as well as to determine the recommended dose in
patients with MDS. This trial consists of two parts, phase 1 part and phase 2 part.
Phase 1 part: The objectives of phase 1 part are to assess the safety of decitabine and to
determine the recommended dose for MDS. The dosage is 15mg/m2/day or 20mg/m2/day by 1-hour
IV infusion for 5 consecutive days. Primary measures of this phase 1 part include adverse
events. In patients enrolled in the phase I part, pharmacokinetics and pharmacodynamics of
decitabine will also be analyzed.
Phase 2 part: The objectives of phase 2 part are to assess the efficacy and safety of
decitabine. The initial dose (dose level 1) is set at 15 mg/m2/day. When the dose of 20
mg/m2/day (dose level 2) is confirmed to be well tolerated in the phase 1 part, patients
will be added to the dose level 2 group until a total number of 26 patients to evaluate the
efficacy and safety of decitabine in the phase 2 part. The primary efficacy endpoint is
remission rate (complete remission + partial remission) at the end of study. One hour
intravenous infusion (using an infusion pump) for 5 consecutive days
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and recommended dose in phase 1 part. To assess the efficacy by remission rate (complete remission + partial remission) in phase 2 part.
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center